Reported Apr 3, 2019 · Terminated
Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER…
GE Healthcare, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Integrated ECG cable with 3-lead
- leadwires labeled as the following
1. ECG TRUNK CABLE3-LD W/ INTEGRATED GRABBER LEAD WIREAHA3.6 M/12 FT2. ECG TRUNK CABLE3-LD W/ INTEGRATED GRABBER LEAD WIREIEC3.6
- M/12 FT Product UsageThe reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only
- Lot codes and dates
1. Catalog Number 2106309-001GTIN 008406821379282. Catalog Number 2106309-002GTIN 00840682137829
- Amount recalled
- 288 devices (23 US, 265 OUS)
Where it was sold
Why it was recalled
The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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