Philips Ultrasound mL26-8 Transducer Probe Labeling Clarification Recall
Philips Ultrasound is recalling 171,322 mL26-8 Transducer Probe units nationwide to provide clarification and labeling defining the useful life of these ultrasound transducers in clinical use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III medical device recall issued to provide labeling clarification defining the useful life of ultrasound transducers. No adverse events, device malfunctions, or patient injuries have been reported; the recall is documentation-focused and precautionary in nature.
Plain-English summary
Philips Ultrasound, Inc is recalling 171,322 units of the mL26-8 Transducer Probe (Model No. 989606722361) that were distributed nationwide in the United States. This device is an ultrasound transducer probe used in medical ultrasound systems for diagnostic imaging.
The recall has been issued to provide clarification and labeling that defines the useful life of ultrasound transducers in the field. The updated labeling will help healthcare facilities understand the appropriate operational duration and lifespan of these devices.
The affected units include multiple serial numbers and UDI codes as documented by Philips Ultrasound. Healthcare providers who use this device should refer to updated labeling information from the manufacturer regarding the defined useful life of the mL26-8 Transducer Probe.
The recalled product
- Product
- mL26-8 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-defect
- durability-information
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. 989606722361
- UDI: (01)00884838108592(21)F08WYR
- 010088483810859221F0GDHW
- 010088483810859221F0GDJ0
- (01)00884838108592(21)F0LCBL
- (01)00884838108592(21)F0JX0Q
- (01)00884838108592(21)F0GT0X
- (01)00884838108592(21)F0KVCN
- (01)00884838108592(21)F0LC9H
- (01)00884838108592(21)F0H4DG
- (01)00884838108592(21)F0J4J8
- (01)00884838108592(21)F0HX31
- (01)00884838108592(21)F0LQC4
- (01)00884838108592(21)F0LQBV
- (01)00884838108592(21)F0JX1C
- (01)00884838108592(21)F0LC9M
- (01)00884838108592(21)F0LC9X
- (01)00884838108592(21)F0DM3Y
- (01)00884838108592(21)F0KC82
- (01)00884838108592(21)F0J4J6
Distribution
Distributed nationwide across the United States.
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