ALPHAMAXX Mobile Operating Table Charger Defect Poses Equipment Failure Risk
Getinge has recalled 7 ALPHAMAXX mobile operating tables due to a defective charger unit that may not charge properly, risking equipment operational failure during use.
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 a FDA Class II recall of medical equipment with no reported injuries or illnesses. The defective charger poses a risk of operational failure in a critical surgical instrument, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Getinge Usa Sales Inc is recalling 7 units of the ALPHAMAXX Mobile Operating Table, Model 113322F5, due to a defective charger unit (part 0970.2873). The defect affects operating tables with serial numbers 409, 410, 411, 413, 414, 415, and 416.
The charger unit may fail to charge the table adequately, risking equipment operational failure during use. No injuries or illnesses have been reported to date.
The affected units have been distributed domestically in Kentucky, North Carolina, New York, and Virginia, as well as internationally to 25 countries worldwide. Customers who own or operate any of the recalled units should contact Getinge Usa Sales Inc immediately for further instructions.
The recalled product
- Product
- ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
- Manufacturer
- Getinge Usa Sales Inc
- Affected units
- 7
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 (4)
- Model Number/Part Number: 113322F5
- UDI/DI: 04046768040052
- Serial Numbers: 409 through 411
- 413 through 416.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Getinge Usa Sales Inc 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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