GE Healthcare Recalls Datex-Ohmeda Anesthetic Cassettes for Quality Control Issues
GE Healthcare is recalling two Datex-Ohmeda AISYS CS2 Aladin2 cassettes because they were shipped without proper evaluation and may be nonconforming.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a quality control issue (shipped without evaluation) without reporting any specific injuries, illnesses, or hospitalizations. This aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
GE Healthcare, LLC is recalling two units of the Datex-Ohmeda AISYS CS2 Aladin2 Cassette, model 1100-9034-000. These cassettes are intended to be used to deliver anesthetic agents. The specific units involved are identified by manufacturing lot or serial numbers BGBQ00675 and BGBQ01187.
The recall was initiated because the non-conforming devices were shipped from the service center without proper evaluation. As a result, the devices may be nonconforming. The affected units were distributed in the United States to the states of Arizona, Illinois, North Carolina, New Hampshire, and Pennsylvania.
Healthcare facilities and consumers who possess these specific cassettes should stop using them immediately and contact GE Healthcare for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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