Pacific Medical Ultrasound Transducers Recalled for Unverified Service Components
Pacific Medical Group is recalling 1,994 ultrasound transducers serviced with unverified non-OEM components, which may cause inaccurate fetal and maternal monitoring.
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 involves a Class II medical device with potential for significant injury, including patient/clinician burns and delayed detection of fetal distress, which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Pacific Medical Group Inc. is recalling 1,994 Ultrasound Transducers (M1356A) 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 December 18, 2014, and April 2, 2019, and were distributed worldwide, including in the United States and various international locations.
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. Additionally, the devices may lack electrocardiography tracing, cause patient or clinician burns, and delay the detection of maternal or fetal distress.
Healthcare facilities and consumers should stop using the affected ultrasound transducers immediately. Pacific Medical Group is the recalling firm responsible for addressing this safety issue.
The recalled product
- Product
- Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical Philips M1356A Ultrasound Cable Assembly, NFPH9520; Pacific…
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 1,994
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 12/18/14 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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