Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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)

FDA Recall Z-1226-2022 · Posted 2022-06-06

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2022-04-18
Product Quantity34,940 ventilators

Reason for Recall

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

Firm Action

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter the consignees via mail on 04/18/2022. The letter describes the product, problem and actions to be taken. The customers instructed to take the following actions: 1. You can continue to use the affected ventilators while the ventilator is connected to an AC mains power source that is supported by backup emergency power. 2. If it is absolutely necessary to use the ventilator by relying on the battery (such as during required transport where there are no other options), ensure you follow standard clinical practice of having a readily accessible means of appropriate alternative ventilation (for example a bag-valve system) and personnel with the capability to administer this alternative means at all times. 3. Immediately after receiving this communication, perform the Battery Performance Test as described in Appendix A. Replace the batteries when necessary, before patient use. 4. When not in patient use, it is recommended that the device always remains connected to the AC mains power source to prevent battery discharge and degradation, even when in storage. 5. It is recommended that the Battery Performance Test be completed every three months as described in Appendix A. 6. If the device has been in storage for over three months, perform the Battery Performance Test as described in Appendix A prior to use. 7. The backup batteries must be replaced at a minimum every three years. 8. Complete the attached Medical Device Notification Acknowledgement Response form and send to [email protected] If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111116ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011-09-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑