Philips Ultrasound Transducers Recalled: Refurbished Beyond Useful Life
Philips is recalling 5,230 ultrasound transducers that were refurbished beyond their useful life. Devices may not perform as designed and should not be used.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall with a theoretical hazard (devices refurbished beyond their useful life). No illnesses or injuries are reported in the source text. Per the rubric, theoretical hazards without reported harm are capped at a maximum of 3 (High).
Plain-English summary
Philips Ultrasound, Inc. is recalling 5,230 Philips L12-3 Transducer units that were refurbished beyond their useful life. The affected devices were distributed throughout the United States and internationally to over 50 countries.
Devices that have been refurbished beyond their useful life may not perform as designed. These ultrasound transducers should not be used for patient care and diagnostic imaging procedures until further guidance is provided.
Healthcare facilities and clinics should immediately stop using these recalled devices. Contact Philips Ultrasound, Inc. for instructions regarding replacement units, device repairs, or return procedures. Patients who may have undergone ultrasound procedures with these devices should consult their healthcare provider with any health concerns.
The recalled product
- Product
- Philips L12-3 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-malfunction
- refurbishment-defect
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.989605412072
- 989605412071
- 989605438571
- 989605348241
- UDI: (01)00884838061620(21)B0TLJT
- (01)00884838061620(21)B10GRD
- (01)00884838061620(21)B0PYG5
- (01)00884838061620(21)B0HF63
- (01)00884838061620(21)B0WMR0
- (01)00884838061620(21)B15HGH
- (01)00884838061620(21)B0Q3CK
- (01)00884838061620(21)B0K211
- (01)00884838061620(21)B138Y9
- (01)00884838061620(21)B11C62
- (01)00884838061620(21)B0NK8H
- (01)00884838061620(21)B1396N
- (01)00884838061620(21)B139FV
- (01)00884838061620(21)B0PY5N
- (01)00884838061620(21)B16XQR
- (01)00884838061620(21)B126FZ
Distribution
Distributed nationwide across the United States.
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