Philips Ultrasound VL13-5 Transducer Labeling Clarification
Philips Ultrasound is clarifying labeling on 171,322 VL13-5 transducer probes distributed nationwide to better define the useful life of the equipment.
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 is a Class III FDA recall focused on labeling clarification with no reported injuries or illnesses. The recall addresses a documentation issue by providing updated labeling to define product useful life, which the severity rubric identifies as typical of the lowest severity category.
Plain-English summary
Philips Ultrasound, Inc. is clarifying labeling for its VL13-5 Transducer Probe to define the useful life of the equipment. The recall affects approximately 171,322 units that have been distributed nationwide in the United States.
This is classified as a Class III action by the FDA. The labeling clarification is intended to define the useful life of ultrasound transducers in clinical field use.
Healthcare facilities and clinicians using these devices should review the clarified labeling information provided by Philips Ultrasound regarding the defined useful life.
The recalled product
- Product
- VL13-5 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Category
- Medical Device
- Hazard
- mis-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. 989605409592
- 989605439931
- UDI: (01)00884838061606(21)B2LKRC
- (01)00884838061606(21)B1RY95
- (01)00884838061606(21)B26B50
- (01)00884838061606(21)B29K57
- (01)00884838061606(21)B1GK0X
- (01)00884838061606(21)B285DN
- (01)00884838061606(21)B285DP
- (01)00884838061606(21)B2865W
- (01)00884838061606(21)B2DW9V
- (01)00884838061606(21)B252D1
- (01)00884838061606(21)B20XP7
- (01)00884838061606(21)F010PF
- (01)00884838061606(21)B2865X
- (01)00884838061606(21)B20YTN
- (01)00884838061606(21)B21T6J
- (01)00884838061606(21)B2281P
- (01)00884838061606(21)B2G3L0
- (01)00884838061606(21)B29DGY
Distribution
Distributed nationwide across the United States.
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