Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 34,940 backup batteries used in four models of ventilators: CARESCAPE R860, ENGSTROM, ENGSTROM Carestation, and ENGSTROM PRO. The batteries have insufficient backup power and may cause the ventilators to shut down prematurely when not connected to an AC power supply. The affected ventilators have been distributed worldwide, including throughout the United States and internationally to countries including Canada, United Kingdom, Australia, Brazil, China, Mexico, and others.
The recall affects ventilators with specific model and serial numbers listed in the recall notice. The source does not specify a remedy or corrective action for consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Reason for recall: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. Distribution: Worldwide Distribution: US (nationwide) to AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and OUS (internationally) to Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Cote D'Ivoire, Mexico, Uruguay, United Kingdom, United Arab Emirates, Turkey, Thailand Quantity: 34,940 ventilators Lot/code info: a. Model Number: 1506-8600-000 and/or 1506-8600-000-XXXXXX; UDI/DI Number:00840682102346; Serial Numbers: CBRZ06959, CBRZ80171, CBRZ80257, CBRZ40111, CBRZ85239, CBRZ05811, CBRZ05833, CBRZ05850, CBRZ05852, CBRZ05857, CBRA01434, CBRA01435, CBRA01436, CBRZ80137, CBRZ80153, CBRZ80197, CBRZ84891, CBRA01744, CBRA01745, CBRA01746, CBRA01747, CBRA01748, CBRA01751, CBRA01756, CBRZ85298, CBRZ85300, CBRZ85305, CBRZ85338, CBRZ07643, CBRZ07668, CBRZ07678, CBRZ07690, CBRZ07691, CBRZ81955, CBRZ82059, CBRZ85119, CBRA01503, CBRA01506, CBRZ03482, CBRZ03483, CBRZ03492, CBRZ03494, CBRA01674, CBRA01675, CBRA01676, CBRA01677, CBRA01678, CBRA01679, CBRA01680, CBRA01681, CBRA01682, CBRA01683, CBRA01684, CBRA01685, CBRA01686, CBRA01687, CBRA01688, CBRZ07601, CBRZ07612, CBRZ07624, CBRZ07632, CBRZ07638, CBRZ07640, CBRZ07641, CBRZ07652, CBRZ07657, CBRZ07660, CBRZ07666, CBRZ07680, CBRZ07682, CBRZ07686, CBRZ07688, CBRZ07692, CBRZ07693, CBRZ07696, CBRZ85174, CBRZ85187, CBRZ85322, CBRA01742, CBRA01743, CBRA01749, CBRA01750, CBRA01752, CBRA01753, CBRA01754, CBRA01755, CBRZ07655, CBRZ07656, CBRZ06919, CBRZ06968, CBRZ80366, CBRZ06920, CBRZ85184, CBRZ85318, CBRZ80149, CBRZ80170, CBRZ80180, CBRZ80259, CBRZ80304, CBRZ06444, CBRZ06445, CBRZ06446, CBRZ06455, CBRZ06456, CBRZ06459, CBRZ06460, CBRA00011, CBRW00623, CBRW00639, CBRW00643, CBRA00053, CBRA00104, CBRA00115, CBRA01757, CBRA01758, CBRA01759, CBRA01789, CBRA01791, CBRA01794, CBRA01795, CBRY02720, CBRY02730, CBRY02736, CBRZ03493, CBRZ81752, CBRZ82162, CBRZ8220
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.