Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Reason for recall: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). Distribution: US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None Lot/code info: Software v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) UDIs: 10885403960123 10885403519666 (10885403960116)
10885403960123, 10885403519666, 10885403960116
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.