Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
External Toco Transducer (M1355A) Recalled by Pacific Medical Group Inc. Due to Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pacific Medical Group Inc. directly.
Affected Products
External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH9320; Pacific Medical Philips M1355A Toco Gauge, NFPH9340
Quantity: 1603
Why Was This Recalled?
Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pacific Medical Group Inc.
Pacific Medical Group Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report