Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engst
Summary
The FDA issued a Class I for Replacement back up batteries distributed on or after April 1, 2019, for CARESCA by GE Healthcare, LLC. Reason: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply..
Details
Source
Device Recall
External ID
Z-1227-2022
Action Date
2022-06-15
Status
Ongoing
Category
device
Product Description
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
Lot/Code Info: 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).
Quantity Affected: 88,379 batteries
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, 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-18
Company
Waukesha, WI
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 178 device recalls issued in the same week, part of 413 device-related FDA actions this month.
GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Healthcare, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Healthcare, LLC have FDA actions?
GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1227-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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