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U.S. Department of Health and Human Services

Class 2 Device Recall Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View

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 Class 2 Device Recall Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire Viewsee related information
Date Initiated by FirmApril 25, 2022
Create DateJune 24, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1286-2022
Recall Event ID 90137
510(K)NumberK172045 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductField replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
Code Information Field Replacement Units (FRU) Battery kits - PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) or PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR), that may have been installed by the customer into any of the following anesthesia systems: o Avance 1009-9002-000 o Aespire View 1009-9212-000 o Avance CS2 and Avance CS2 Pro 1009-9050-000
FEI Number 2126677
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactGE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		Backup batteries can fail earlier than their estimated life.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn Urgent Medical Device Correction letter dated 04/25/2022 was sent to customers with affected devices. The letter mentions the users can continue to use the ventilator while connected to an AC mains power source that is supported by backup emergency power. The letter provides a series of recommendations for the consignee to follow. The letter also requests that the consignee complete the medical device notification acknowledgement response form and send it back to the firm.
Quantity in Commerce88,347 batteries
DistributionWorldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Kenya, Korea, Kuwait, Lao PDR, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Nepal, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSZ
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