Pacific Medical Ultrasound Transducers Recalled for Missing Clearances
Pacific Medical Group Inc. is recalling 225 ultrasound transducers distributed before receiving required FDA and international clearances.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II and involves a regulatory compliance issue (distribution before clearance) rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pacific Medical Group Inc. is recalling 225 units of the Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, model FFPH5250. The recall involves all serial numbers sold between January 21, 2015, and April 30, 2019.
The recall was initiated because the fetal transducers were distributed in advance of receiving 510(k) and international clearances. The devices were distributed across 45 U.S. states and the District of Columbia, as well as in Canada, Colombia, France, Great Britain, Italy, Mexico, and the United Arab Emirates.
Consumers and healthcare facilities should stop using the affected transducers and contact Pacific Medical Group Inc. for further instructions.
The recalled product
- Product
- Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 225
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 sold between 01/21/2015 - 04/30/2019
Distribution
Part of a larger recall action
This product is one of 7 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.
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