FDA Medical Device Recalls (openFDA)
Getinge Usa Sales Inc: ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
- Recall number
- Z-2272-2024
- Recalling firm
- Getinge Usa Sales Inc
- Product
- ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
- Status
- Open, Classified
- Initiated
- 2024-05-29
- Posted
- 2024-07-05
- Terminated
- not on file
- 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.
- Root cause
- Component design/selection
- Action
- On May 29, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken by the Customer: Our records indicate that you have received one or more of the ALPHAMAXX Mobile Operating Table from the affected Product Code/Part Number 1133.22F5. Please examine your inventory immediately to determine if you have any of the ALPHAMAXX Mobile Operating Table (1133.22F5) with the Product REF number listed in this notice. The device can be used in accordance with the instructions for use, with extra attention to the following: 1. The battery status is displayed on the override panel of the operating table (IFU113322XYEN18_01 - 4.3 Override control panel). This is visible to the user at any time. 2. It is pointed out in the instruction for use (IFU113322XYEN18_01 5.2.4 Battery operation) that the operating table should be charged when the battery status is low. Whether or not you have affected product(s) with the Product REF numbers, please complete, and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to maquet.gmbhalphamaxx.sw.qrc@getinge.com or by faxing the form to 1- 866- 575- 5658. Please forward this information to all current and potential ALPHAMAXX Mobile Operating Table users within your hospital/facility. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Type of Action by Maquet/Getinge: *Maquet/Getinge has developed a solution that will correct this issue. A Getinge Service Representative will contact you to schedule the correction. This work will be done at no cost to your facility. Adverse reactions or quality problems experienced with the use of any of the products identified on Pages 1 and 2 may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax usi
- Quantity
- 171 Units
- 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.
- Lot, serial or model codes
- Model Number/Part Number: 113322B5; UDI/DI: 04046768040014; Serial Numbers: 2059 through 2183, 2185 through 2204, 2206, 2208, 2209, 2211 through 2231, 2233, 2235.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQO
- Firm FEI
- 3013876692
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28