Philips Ultrasound, Inc — L12-5 38mm Transducer Probe
⚠️ To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 3, 2025
US Nationwide distribution.
What's affected?
- Product
- L12-5 38mm Transducer Probe
- Lot code
- Model No. 989605428532; UDI: (01)00884838073623(21)B305XD, (01)00884838073623(21)F05R7X, (01)00884838073623(21)B1Y35V, (01)00884838073623(21)B305ZX, (01)00884838073623(21)F05K8W, (01)00884838073623(21)B3GWRJ, (01)00884838073623(21)B1Y306, (01)00884838073623(21)B1Y3CG, (01)00884838073623(21)B1Q699, (01)00884838073623(21)B1Y3C4, (01)00884838073623(21)B1RXWK, (01)00884838073623(21)B305X5, (01)00884838073623(21)B305ZK, (01)00884838073623(21)B3NFD5, (01)00884838073623(21)F034C6; Serial No. B305XD, F05R7X, B1Y35V, B305ZX, F05K8W, B3GWRJ, B1Y306, B1Y3CG, B1Q699, B1Y3C4, B1RXWK, B305X5, B305ZK, B3NFD5, F034C6.
Additional details
Model No. 989605428532; UDI: (01)00884838073623(21)B305XD, (01)00884838073623(21)F05R7X, (01)00884838073623(21)B1Y35V, (01)00884838073623(21)B305ZX, (01)00884838073623(21)F05K8W, (01)00884838073623(21)B3GWRJ, (01)00884838073623(21)B1Y306, (01)00884838073623(21)B1Y3CG, (01)00884838073623(21)B1Q699, (01)00884838073623(21)B1Y3C4, (01)00884838073623(21)B1RXWK, (01)00884838073623(21)B305X5, (01)00884838073623(21)B305ZK, (01)00884838073623(21)B3NFD5, (01)00884838073623(21)F034C6; Serial No. B305XD, F05R7X, B1Y35V, B305ZX, F05K8W, B3GWRJ, B1Y306, B1Y3CG, B1Q699, B1Y3C4, B1RXWK, B305X5, B305ZK, B3NFD5, F034C6.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 171,322 units.
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