FDA Device recall Z-1226-2022

Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carest…

FDA Device
Class I
ongoing
Published 2022-06-15

On 2022-06-15 the FDA classified a Class I recall of Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carest… by Ge Healthcare, citing insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1226-2022
Classification	Class I
Status	ongoing
Initiated	2022-04-18
Published	2022-06-15
Last updated	2026-09-13 11:56 UTC
Company	Ge Healthcare
Distribution	US

Product

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)

Reason

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

Identifiers

code_info	a. Model Number: 1506-8600-000 and/or 1506-8600-000-XXXXXX; UDI/DI Number:00840682102346; Serial Numbers: CBRZ06959, CB… 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, CBR

code_info

a. Model Number: 1506-8600-000 and/or 1506-8600-000-XXXXXX; UDI/DI Number:00840682102346; Serial Numbers: CBRZ06959, CB…

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, CBR

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1226-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.