Philips Mini Multi TEE Transducer Probe labeling clarification on device useful life
Philips Ultrasound is clarifying labeling for 171,322 Mini Multi TEE transducer probes to better define the devices' useful life 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 recall addressing labeling and documentation. No injuries, illnesses, or deaths have been reported. The issue involves clarification of device useful life labeling to ensure proper clinical use—a documentation correction without reported safety harm.
Plain-English summary
Philips Ultrasound, Inc. is issuing a recall for the Mini Multi TEE Transducer Probe to provide clarification and labeling regarding the useful life of the ultrasound transducers.
The recall affects 171,322 units that have been distributed nationwide in the United States. The action is being taken to ensure that healthcare providers and clinical staff have clear guidance on the usable lifespan of these transducers in the field.
Affected facilities should implement the updated labeling provided by Philips Ultrasound, Inc. If you have questions about the updated labeling or the useful life of your Mini Multi TEE transducers, contact the manufacturer.
The recalled product
- Product
- Mini Multi TEE Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-deficiency
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 (18)
- Model No. 989605439242
- 21381A
- UDI: (01)00884838067547(21)B0DTV4
- (01)00884838067547(21)B01639
- (01)00884838067547(21)B06NT3
- Serial No. 0341YT
- 0319CQ
- 028NZW
- B0RF1J
- B0F31L
- B0DTV4
- B0C9XR
- 02H0L8
- B0KYGV
- B01639
- B06NT3
- 03C68B
- 03C8CW.
Distribution
Distributed nationwide across the United States.
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