ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5

FDA device recall Z-2272-2024 · posted 2024-07-05 · Open, Classified

Recall details

Recalling firm

Getinge Usa Sales Inc

Reason for recall

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.

Action taken

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

Root cause

Component design/selection

Status

Open, Classified

Product code

FQO

Quantity affected

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,

Date initiated

2024-05-29

Date posted

2024-07-05

Location

Wayne, NJ