CLASS II ONGOING Device recall · Reported 19 Feb 2020 · FDA Enforcement Report
Toco+ transducer with ECG/IUP capability (wired) recalled
Pacific Medical Group is recalling Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the, distributed nationwide in the US. The recall was initiated on 11 Sep 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1166-2020
- FDA event ID
- 83610
- Recalling firm
- Pacific Medical Group, San Clemente, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Sep 2019
- FDA classified
- 12 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Patient Monitors
Timeline
| 11 Sep 2019 | Recall initiated by company | |
| 12 Feb 2020 | Classified by FDA | +154 days |
| 19 Feb 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it 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.
Which lots are affected?
All serial numbers serviced between 9/2/15 and 4/2/19.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 83610This product is part of a recall event; the main page for the event is Ultrasound Transducer (M1356A) recalled by Pacific Medical Group.
More recalls from Pacific Medical Group
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Aftermarket Alaris Infusion Pump Module recalled | Pacific Medical Group | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Ultrasound Transducer (M2736A) recalled by Pacific Medical Group | Pacific Medical Group | Temperature Abuse | Nationwide |
| Device | CLASS II | Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX recalled | Pacific Medical Group | Temperature Abuse | Nationwide |
| Device | CLASS II | External Toco Transducer (M1355A) recalled by Pacific Medical Group | Pacific Medical Group | Temperature Abuse | Nationwide |
| Device | CLASS II | Loop-Style Ultrasound Transducer (Nautilus) recalled | Pacific Medical Group | Temperature Abuse | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |