Mobile Operating Table Charger Defect Poses Risk of Operational Failure
Getinge USA Sales Inc is recalling 171 ALPHAMAXX mobile operating table units due to a defective charger unit that may cause inadequate charging and operational failure.
What this means for you
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 Class II medical device recall with no reported illnesses or injuries. The defective charger poses a risk of operational failure of surgical equipment, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Getinge USA Sales Inc is recalling 171 units of the ALPHAMAXX Mobile Operating Table, Model 113322B5, due to a defective charger unit (part number 0970.2873). The charger defect affects multiple ALPHAMAXX models, including 113322B4, 113322B5, and 113322F5.
The defective charger poses a risk of inadequate charging and operational failure. This could prevent the table from functioning properly during surgical procedures.
Affected units were distributed domestically to Kentucky, North Carolina, New York, and Virginia, as well as internationally to Australia, Bulgaria, Croatia, Czech Republic, Denmark, France, Greece, Hong Kong, Ireland, Israel, Japan, Jordan, Kuwait, Mexico, New Zealand, Norway, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, United Arab Emirates, and the United Kingdom. Affected serial numbers are 2059–2183, 2185–2204, 2206, 2208, 2209, 2211–2231, 2233, and 2235.
The recalled product
- Product
- ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
- Manufacturer
- Getinge Usa Sales Inc
- Affected units
- 171
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 (10)
- Model Number/Part Number: 113322B5
- UDI/DI: 04046768040014
- Serial Numbers: 2059 through 2183
- 2185 through 2204
- 2206
- 2208
- 2209
- 2211 through 2231
- 2233
- 2235.
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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