Pacific Medical Ultrasound Transducers Recalled for Non-OEM Component Use
Pacific Medical Group is recalling 5,897 ultrasound transducers serviced with unverified non-OEM components, which may cause inaccurate monitoring or patient burns.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves potential patient/clinician burns and inability to detect fetal/maternal distress, meeting the criteria for Severe severity.
Plain-English summary
Pacific Medical Group Inc. is recalling 5,897 Ultrasound Transducers (M2736A) that may have been serviced or remanufactured using non-OEM equivalent components. These components have not been appropriately verified or validated. The affected units were serviced between September 2, 2015, and April 2, 2019.
The use of unverified components may result in the inability to accurately detect and measure fetal heart rate, maternal peripheral oxygen saturation, uterine activity, temperature, or maternal blood pressure. It may also lead to a lack of electrocardiography tracing, patient or clinician burns, and delays in detecting maternal or fetal distress.
The recall covers units distributed worldwide, including nationwide in the United States and in specific countries such as Canada, Mexico, and the United Kingdom. Users should stop using the affected transducers and contact Pacific Medical Group for further instructions.
The recalled product
- Product
- Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 5,897
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 (1)
- All serial numbers serviced between 9/2/15 and 4/2/19.
Distribution
Part of a larger recall action
This product is one of 10 recalled by Pacific Medical Group Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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