Z-0543-2021 Class II Terminated
FDA device recall Z-0543-2021 was initiated by GE Healthcare, LLC on October 27, 2020 and is designated Class II. Reason for recall: Incorrect patient identification and/or patient demographic errors. The recall status is terminated (terminated May 3, 2024). Affected quantity: 5,284 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2020
- Initiation Date
- October 27, 2020
- Termination Date
- May 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,284 units
Product Description
Reason for Recall
Distribution Pattern
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.