FDA Enforcement
Class III
Ongoing
C6-3 Transducer Probe
Recall: Z-2356-2025
·
Reported September 3, 2025
Enforcement
- Recall Number
- Z-2356-2025
- Event ID
- 97217
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips Ultrasound, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 3, 2025
- Initiation Date
- July 3, 2025
- Classification Date
- August 22, 2025
- Address
- 1 Echo Dr, Reedsville, PA, 17084-8603, United States
Description
C6-3 Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Code Info
Model No. 989605359593, 989605387371, 989605359594, 989605359591; UDI: (01)00884838067950(21)B20N4N, (01)00884838067950(21)B1WR9H, (01)00884838067950(21)B1RGN0, (01)00884838067950(21)B1MTT4, (01)00884838067950(21)B1N3C4, (01)00884838087170(21)B27LPZ, (01)00884838087170(21)B3W5CM, (01)00884838067950(21)B24KL3, (01)00884838067950(21)B1MTT5, (01)00884838087170(21)B27LQ2; Serial No. B20N4N, B1WR9H, B1RGN0, B1MTT4, B16QBM, B1N3C4, B27LPZ, 03DG3C, B3W5CM, B2ZN6B, B19M3K, B2TJFT, B35M7F, B24KL3, B1MTT5, B32P04, B35MC6, B27LQ2.
Distribution
US Nationwide distribution.
Quantity
171,322 units