Class 2 Device Recall ALPHAMAXX Mobile Operating Table

• Date Initiated by Firm: May 29, 2024
• Date Posted: July 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2273-2024
• Recall Event ID: 94740
• Product Classification: Table, operating-room, ac-powered - Product Code FQO
• Product: ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
• Code Information: Model Number/Part Number: 113322F5; UDI/DI: 04046768040052; Serial Numbers: 409 through 411, 413 through 416.
• Recalling Firm/ Manufacturer: Getinge Usa Sales Inc; 1 Geoffrey Way; Wayne NJ 07470-2035
• Manufacturer 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.
• FDA Determined 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 in Commerce: 7 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.