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43 recalls on record

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Philips North America Llc — Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1

Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

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Philips North America Llc — Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

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Philips North America Llc — Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

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Philips North America Llc — DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.

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Philips North America Llc — Spectral CT 7500 on Rails; Product Code (REF): 728334;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

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Philips North America Llc — IQon Spectral CT; Product Code (REF): 728332;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

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Philips North America Llc — Spectral CT; Product Code (REF): 728333;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

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Philips North America Llc — Brilliance iCT; Product Code (REF): 728306;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

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Philips North America Llc — Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.

It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.

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Philips North America Llc — IntelliVue Patient Monitor MX750. Product Number: 866471.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX800. Product Number: 865240.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP90. Product Number: M8010A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP30. Product Number: M8002A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX700. Product Number: 865241.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX100. Product Number: 867033.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP40. Product Number: M8003A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Multi Measurement Server X2. Product Number: M3002A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP60. Product Number: M8005A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP5. Product Number: M8105A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP20. Product Number: M8001A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX600. Product Number: 865242.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX400. Product Number: 866060.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Multi-Measurement Module X3. Product Number: 867030.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX550. Product Number: 866066.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX450. Product Number: 866062.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP70. Product Number: M8007A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX500. Product Number: 866064.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX850. Product Number: 866470.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP2. Product Number: M8102A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP50. Product Number: M8004A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue MP80. Product Number: M8008A.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

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Philips North America Llc — CT 5300; Software Version Number: 4.5, 5.0, 5.1;

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

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Philips North America Llc — Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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Philips North America Llc — Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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Philips North America Llc — Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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Philips North America Llc — Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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Philips North America Llc — Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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Philips North America Llc — Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model N

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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Philips North America Llc — Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity F

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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Philips North America Llc — Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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Philips North America Llc — Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Sl

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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Philips North America Llc — Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.