CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
Datex-ohmeda Aisys CS2 ALADIN2 Cassette Cassettes recalled
GE Healthcare is recalling Datex-ohmeda Aisys CS2 ALADIN2 Cassette Cassettes are intended to be used to deliver, distributed in Arizona, Illinois, North Carolina, New Hampshire, Pennsylvania. The recall was initiated on 4 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1199-2018
- FDA event ID
- 79493
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Oct 2017
- FDA classified
- 26 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Oct 2017 | Recall initiated by company | |
| 26 Mar 2018 | Classified by FDA | +173 days |
| 4 Apr 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Product as listed by the FDA
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Where it was distributed
US Distribution to states of: AZ, IL NC, NH and PA.
Questions about this recall
Why was it recalled?
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Which lots are affected?
Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187
Where was it sold?
US Distribution to states of: AZ, IL NC, NH and PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 79493| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Datex-ohmeda Tec 7 Anesthesia Vaporizer Is designed recalled | GE Healthcare | Other | 5 states |
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