FDA Enforcement
Class II
Ongoing
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
Recall: Z-2273-2024
·
Reported July 17, 2024
Enforcement
- Recall Number
- Z-2273-2024
- Event ID
- 94740
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Getinge Usa Sales Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 17, 2024
- Initiation Date
- May 29, 2024
- Classification Date
- July 5, 2024
- Address
- 1 Geoffrey Way, N/A, Wayne, NJ, 07470-2035, United States
Description
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
Reason
The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.
Code Info
Model Number/Part Number: 113322F5; UDI/DI: 04046768040052; Serial Numbers: 409 through 411, 413 through 416.
Distribution
Domestic: KY, NC, NY, VA. International: 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, United Kingdom.
Quantity
7 units