Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Brand
Pacific Medical Group Inc.
Lot Codes / Batch Numbers
All serial numbers distributed between 02/06/16 - 04/30/19.
Products Sold
All serial numbers distributed between 02/06/16 - 04/30/19.
Pacific Medical Group Inc. is recalling Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260 due to Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately d. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Fetal transducers distributed in advance of receiving 510(k) and international clearances. 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 interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.
Recommended Action
Per FDA guidance
On 09/19/19, Urgent Medical Device Recall notices were emailed to customers informing them of the following possible failures associated with the post market events: - Fluid damage/intrusion, solder cracks, component failure. - Damaged membrane or cracked case. - Internal short from usage, broken connector from misuse. - Broken leads, loose coil. - Loose crystal from failure of adhesive, internal short or improper grounding. - Miscalibration of the device/waveform. - Overheat of device. Malfunction of the device is likely to be recognized easily because the device will not function properly without intact components. If wave forms are not capturing the clinical data including fetal heart rate, oxygen saturation, patient's temperature or uterine activity, the device should not be used. Immediate actions to be taken by the Customer/User: - Inspect the device before each use to observe for any signs of device damage including cracked case, broken leads, loose coils, or damaged components and immediately remove the device from clinical service. - If any fluid intrusion is noted, remove the device from service immediately. - Any signs that the device is overheating should be recognized as a potential serious issue and should not be used and/or removed from the patient immediately. - If waveforms are not capturing on the monitor or there is artifact, this may be due to miscalibration of the device or a component malfunction. Remove the device from service. You may continue to utilize the affected devices as the recalling firm reasonably believes use of, exposure to, the affected products is not likely to cause adverse health consequences. Complete and return the customer acknowledgement form to the recalling firm. If you have subsequently resold or distributed the affected product, please ensure that this information is provided to your customer(s). Customers with additional questions or complaints are encouraged to call (800) 449-5328.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, DC
Page updated: Jan 10, 2026