GE Healthcare, LLC: Medical Device Recall in 2022 - (Recall #: Z-1227-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.

Product Classification:

Class I

Date Initiated: April 18, 2022

Date Posted: June 15, 2022

Recall Number: Z-1227-2022

Event ID: 90076

Reason for Recall:

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

Status: Ongoing

Product Quantity: 88,379 batteries

Code Information:

Field Replacement Unit kits PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) and PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR).

Distribution Pattern:

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, Tanzania, Sweden, Spain, Singapore, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Panama, Omar, Norway, Nigeria, Nicaragua, New Zealand, Netherlands, Malaysia, Latvia, Kuwait, Korea, Kenya, Kazakhstan, Japan, Italy, Ireland, Indonesia, India, Hungary, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic.

Voluntary or Mandated:

Voluntary: Firm initiated