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U.S. Department of Health and Human Services

Class 2 Device Recall Aisys CS2 Aladin Cassette

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 Class 2 Device Recall Aisys CS2 Aladin Cassettesee related information
Date Initiated by FirmOctober 04, 2017
Create DateMarch 26, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall NumberZ-1199-2018
Recall Event ID 79493
510(K)NumberK170872 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductDATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Code Information Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187
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		Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
FDA Determined
Cause 2		Process control
ActionThe firm, GE healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 4th, 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact GE Service to obtain an RMA number. GE Healthcare has arranged with Piramal Inc. to replace the affected products at no cost. If you have any questions or concern regarding this notification please contact GE healthcare Service at 1-800-437-1171 or your local representative.
Quantity in Commerce2
DistributionUS Distribution to states of: AZ, IL NC, NH and PA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BSZ
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