Atlan Anesthesia Machine Backup Battery May Fail Unexpectedly During Operation
Draegerwerk has recalled Atlan A350 and A350 XL anesthesia machines because the internal backup battery may fail unexpectedly, potentially causing device shutdown during operation. No injuries or device failures have been reported.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a critical-care anesthesia delivery system where unexpected device shutdown due to battery failure could result in serious patient harm. The score reflects the rubric criterion for risk-of-harm products where injury has not yet been reported, since no hospitalizations, injuries, or device failures have been documented, and affected units have not reached end-users.
Plain-English summary
Draegerwerk Ag & Co. KgaA has recalled the Atlan Gas Machine for Anesthesia or Analgesia, specifically Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL). Affected lot numbers include ASSH-0220 through ASSH-0254 and ASSL-0347 through ASSL-0361.
The internal backup battery in these devices may fail spontaneously when the machine is operating without AC mains power. If the battery fails during operation, the device will shut down unexpectedly while delivering anesthesia or analgesia to a patient.
Approximately 50 units of the affected models were imported to the United States but none have been distributed to end-users. All units currently remain under the direct control of Draeger, Inc. and have not reached hospitals, surgery centers, or other medical facilities.
No device failures or patient injuries have been reported. Draegerwerk initiated this recall as a precautionary measure. Healthcare facilities or other parties who may possess one of these units should contact the manufacturer immediately for guidance on device status and recall procedures.
The recalled product
- Product
- Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
- Manufacturer
- Draegerwerk Ag & Co. Kgaa
- Affected units
- 50
Distribution
Distribution scope not specified by the agency.
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