Z-1700-2020 Class II Terminated
FDA device recall Z-1700-2020 was initiated by Abbott on February 28, 2020 and is designated Class II. Reason for recall: Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and th… The recall status is terminated (terminated April 18, 2024). Affected quantity: Software Version 24.6.1 installed into 4733 programmers.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2020
- Initiation Date
- February 28, 2020
- Termination Date
- April 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Software Version 24.6.1 installed into 4733 programmers
Product Description
Reason for Recall
Distribution Pattern
U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees associated to ICDs that were interrogated from January 22, 2020 to February 6, 2020.