FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
- Recall number
- Z-1199-2018
- Recalling firm
- GE Healthcare, LLC
- Product
- DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
- Status
- Terminated
- Initiated
- 2017-10-04
- Posted
- not on file
- Terminated
- 2020-04-10
- Reason
- Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 2
- Distribution
- US Distribution to states of: AZ, IL NC, NH and PA.
- Lot, serial or model codes
- Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187
- 510(k) numbers
- ["K170872"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28