FDA Medical Device Recalls (openFDA)
Pacific Medical Group Inc.: Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
- Recall number
- Z-0984-2020
- Recalling firm
- Pacific Medical Group Inc.
- Product
- Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
- Status
- Open, Classified
- Initiated
- 2019-09-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- Root cause
- No Marketing Application
- Action
- 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.
- Quantity
- 261
- Distribution
- U.S.: IN, AZ, IL, HI, AK, AR, CA, FL, GA, IA, ID, LA, MA, NC, NE, NM, NY, OK, PA, TN, TX, UT, VA, WA, WV, NV, KY, CO, ME, ND, OH, SC, WI, AL, OR, DC, DE, MD, MI, MN, MO, MT, MS, NJ, NH. O.U.S. (Foreign): CA, CO, FR, GB, IT, MX, UAE
- Lot, serial or model codes
- All serial numbers sold between 10/24/2014 - 04/30/2019
- 510(k) numbers
- ["K140535"]
- PMA numbers
- not on file
- Product code
- HGM
- Firm FEI
- 3007409280
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28