—#162482

Product

DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.

FDA product code: BSZ — Gas-Machine, Anesthesia
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K170872
Affected lot / code info: Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187

Why it was recalled

Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

Root cause (FDA determination)

Process control

Action the firm took

The 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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: US Distribution to states of: AZ, IL NC, NH and PA.

Timeline

Recall initiated: 2017-10-04
Terminated: 2020-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162482. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.