MAC VU360, Electrocardiograph
Reported: December 16, 2020 Initiated: October 27, 2020 #Z-0543-2021
Product Description
MAC VU360, Electrocardiograph
Reason for Recall
Incorrect patient identification and/or patient demographic errors.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 5,284 units
- Distribution
- Domestic Distribution: AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International Distribution: AUSTRALIA, AUSTRIA, BELGIUM, Canada, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, Germany, Hong Kong, IRELAND, ISRAEL, ITALY, Korea, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, QATAR, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, United Kingdom.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
MAC VU360, Electrocardiograph. Recalled by GE Healthcare, LLC. Units affected: 5,284 units.
Why was this product recalled? ▼
Incorrect patient identification and/or patient demographic errors.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0543-2021.
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