Philips C9-4 Ultrasound Transducer Probe Labeling Clarification Recall
Philips Ultrasound is recalling the C9-4 Transducer Probe (171,322 units) nationwide to provide labeling clarification about the device's useful life.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III device recall for labeling clarification. The issue is a documentation matter regarding the definition of useful life. No reported illnesses, injuries, adverse events, or functional defects in the device.
Plain-English summary
Philips Ultrasound, Inc. is recalling the C9-4 Transducer Probe (Model Nos. 989605365021, 989605365023, 989605387291) distributed nationwide. Approximately 171,322 units are affected. The recall is being issued to provide clarification and labeling to properly define the useful life of these ultrasound transducers in the field.
The C9-4 Transducer Probe is a medical ultrasound transducer device used in diagnostic imaging systems. The purpose of this recall is to ensure that labeling clearly specifies the useful life parameters.
Healthcare facilities with this device should review updated labeling materials from Philips Ultrasound regarding the device's useful life and follow the manufacturer's guidance for continued clinical use and replacement.
The recalled product
- Product
- C9-4 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- inadequate-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 989605365021
- 989605365023
- 989605387291
- UDI: (01)00884838064607(21)B1FZ1B
- (01)00884838064607(21)B2KL13
- (01)00884838064607(21)B30GDB
- (01)00884838064607(21)B33HMW
- (01)00884838064607(21)B3CL5L
- (01)00884838064607(21)B1VKTB
- (01)00884838064607(21)B2KL31
- (01)00884838064607(21)B2JZ44
- (01)00884838064607(21)B3GX1T
- (01)00884838064607(21)B1XRF3
- (01)00884838064607(21)B34QB8
- (01)00884838064607(21)B1GFMQ
- (01)00884838064607(21)B1RYG9
- (01)00884838064607(21)B23TC6
- (01)00884838064607(21)B1XRF1
- (01)00884838064607(21)B1XN5J
- (01)00884838064607(21)B1RYG6
Distribution
Distributed nationwide across the United States.
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