Philips D2TCD Ultrasound Transducer Probes Labeling Clarification Recall
Philips is recalling approximately 171,322 D2TCD Transducer Probes nationwide to provide clarification and labeling regarding the useful life of ultrasound transducers.
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 FDA Class III medical device recall addressing labeling and documentation clarification. No hazards, illnesses, injuries, or incidents are reported in the source material. The recall is documentation-focused, fitting the 'Low' category for documentation issues.
Plain-English summary
Philips Ultrasound, Inc. is recalling approximately 171,322 units of the D2TCD Transducer Probe distributed nationwide in the United States. The recall was issued to provide clarification and labeling to define the useful life of ultrasound transducers in clinical use.
The affected units include Model Numbers 989605412102 and 989605438591, along with multiple associated serial numbers and UDI batch codes listed in the FDA recall notice. All units distributed to healthcare facilities and providers in the US are subject to this recall.
Philips is implementing labeling updates to clarify and define the useful life parameters for these ultrasound transducers. Healthcare facilities and providers should contact Philips for updated labeling information and refer to FDA recall number Z-2367-2025 for complete details on the affected product codes and appropriate next steps.
The recalled product
- Product
- D2TCD 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 (20)
- Model No. 989605412102
- 989605438591
- UDI: (01)00884838061361(21)B1N4HT
- (01)00884838061361(21)B1N4J6
- (01)00884838061361(21)B2L6QZ
- (01)00884838061361(21)B2L6R0
- (01)00884838061361(21)B2L6T9
- (01)00884838061361(21)F01C9Y
- (01)00884838061361(21)F074NX
- (01)00884838061361(21)B2Q7FK
- (01)00884838061361(21)F08MVZ
- (01)00884838061361(21)B1NDJD
- (01)00884838061361(21)B1N4JF
- (01)00884838061361(21)B2L6TV
- (01)00884838061361(21)F05Z77
- (01)00884838061361(21)B2Q71X
- (01)00884838061361(21)F0998F
- (01)00884838061361(21)F0998J
- (01)00884838061361(21)F09WC4
- (01)00884838061361(21)F02H8Q
Distribution
Distributed nationwide across the United States.
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