Z-1164-2020Class II

Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips...

Name: Z-1164-2020 Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips...
Creator: Pacific Medical Group Inc.
Published: 2019-09-11
License: https://open.fda.gov/license/

Pacific Medical Group Inc. / initiated 2019-09-11 / Open, Classified / root cause: design

FDA source

Pacific Medical Group Inc. began a recall of Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical... on 2019-09-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1164-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-11
Posted: 2020-02-12
Recalling firm: Pacific Medical Group Inc.
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 Medical Philips M1356A Ultrasound M1356A Crystal, NFPH9535
Product code: HGL Transducer, Ultrasonic, Obstetric
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: On 09/11/19, gent Medical Device Recall notices were emailed to customers. Customers were advised of the following possible failures associated with the post-market events: 1) Fluid damage/intrusion, solder cracks, component failure, 2) Damaged membrane or cracked case, 3) Internal short from usage, broken connector from misuse, 4) Broken leads, loose coil, 5) Loose crystal from failure of adhesive, internal short or improper grounding, 6) Miscalibration of the device/waveform, 7) 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. If there are no signs of product damage or deterioration, the serviced devices may continue to be used with continued monitoring of device performance. Maintain this notification at your facility and review the content of this letter with your staff. 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 additio
Quantity in commerce: 1994
Distribution: Worldwide Distribution - US Nationwide in the states of::NH, NY, MN, PA, FL, AZ, LA, GA, IL, HI, CA, OR, SC, OH, NC, IA, OK, AL, MA, MD, WI, MI, AR, WA, SD, NV, KY, TX, MS, DE, NJ, NE, WV, MT, TN, VA, MO, VT, CO, CT, ME, WY, IN, UT, NM, AK, DC, ID, KS, ND, RI, NH. OUS: BEL, ARE, MEX, CAN, CYM, KOR, ZAF, BHR, ESP, ITA, FRA, VUT, AUS, GBR.
Product codes and lots: All serial numbers serviced between 12/18/14 and 4/2/19.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1164-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1159-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1160-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1161-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1162-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1163-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1164-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1165-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1166-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1167-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1168-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12

Product code HGL

K012718Class IIModification to Corometrics Model 120Is Maternal/fetal Monitoring System.Ge Medical Systems Information Technologies / cleared 2001-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)