Getinge Recalls ALM XTEN Surgical Lights Due to Broken Spring Arms
Getinge is recalling 667 ALM XTEN Surgical Lights because spring arms may crack and break, causing light heads to separate.
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: The recall involves a medical device with a mechanical defect that could cause the light head to separate during use, posing a risk of harm, but no injuries or illnesses have been reported.
Plain-English summary
Getinge US Sales LLC is recalling 667 units of the ALM XTEN Surgical Light, part numbers ARD567801093 and ARD567801094. The devices are intended to provide visible illumination for the surgical field or for the examination of the patient.
The recall is due to complaints that the spring arms on the surgical lights have broken, causing the light heads to separate from the assembly. The issue is related to cracking of the spring arms at the weld seams, which has the potential to develop into breaks with heavy use and aging of the equipment.
The affected units were distributed to U.S. and government accounts. Users should check their serial numbers against the list provided in the official recall notice and contact Getinge for further instructions.
The recalled product
- Product
- ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
- Manufacturer
- GETINGE US SALES LLC
- Affected units
- 667
Distribution
Distribution scope not specified by the agency.
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