Philips XL14-3 Transducer Probes recalled for labeling clarification on useful life
Philips Ultrasound is recalling 171,322 XL14-3 Transducer Probes for labeling clarification to define the product's useful life in the field.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This FDA Class III recall addresses labeling clarification regarding product useful life. FDA Class III recalls are typically scored 1 or 2 per the severity rubric. The correction is documentary and clarification in nature, placing it in the Low severity category.
Plain-English summary
Philips Ultrasound, Inc is recalling 171,322 XL14-3 Transducer Probes distributed nationwide in the United States.
The recall is being issued to provide clarification and labeling defining the useful life of ultrasound transducers in the field.
Healthcare professionals and facilities with affected units should contact Philips Ultrasound, Inc regarding the labeling clarifications for this product.
The recalled product
- Product
- XL14-3 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-clarification
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. 989605409251
- 989605492481
- UDI: (01)00884838074613(21)B372N5
- (01)00884838074613(21)F02DPY
- (01)00884838074613(21)B3MY7N
- (01)00884838074613(21)B3823F
- (01)00884838074613(21)B3823J
- 010088483807461321F026YH
- (01)00884838074613(21)F03KJH
- (01)00884838074613(21)F03G0Y
- (01)00884838074613(21)F03MFH
- (01)00884838074613(21)F03MFL
- (01)00884838074613(21)F03MFN
- (01)00884838074613(21)F09RZ3
- (01)00884838074613(21)F07HBJ
- (01)00884838074613(21)F0HDCN
- (01)00884838074613(21)B3KTRR
- (01)00884838074613(21)B33MYL
- (01)00884838074613(21)B2DYZ8
- (01)00884838074613(21)F009PY
Distribution
Distributed nationwide across the United States.
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