Class 2 Device Recall MedRiser MR600 Patient Lift

• Date Initiated by Firm: February 03, 2023
• Date Posted: March 02, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1204-2023
• Recall Event ID: 91695
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: Med-Riser MR600 Patient Lift
• Code Information: UDI-DI: 00852195007308; Serial No.: MR600000, MR600001, MR600002, MR600003, MR600004, MR600005, MR600006, MR600007, MR600008, MR600009, MR600010, MR600011, MR600012, MR600013, MR600014, MR600015, MR600016, MR600017, MR600018, MR600019, MR600020, MR600021, MR600022, MR600023, MR600024, MR600025, MR600026, MR600027, MR600028, MR600029, MR600030, MR600031, MR600032, MR600033, MR600034, MR600035, MR600036, MR600037, MR600038, MR600039, MR600040, MR600041, MR600042, MR600043, MR600044, MR600045, MR600046, MR600047, MR600048, MR600049, MR600050, MR600051, MR600052, MR600053, MR600054, MR600055, MR600056, MR600057, MR600058, MR600059, MR600060, MR600061, MR600062, MR600063, MR600064, MR600065, MR600066, MR600067, MR600068, MR600069, MR600070, MR600071, MR600072, MR600073, MR600074, MR600075, MR600076, MR600077, MR600078, MR600079, MR600080, MR600081, MR600082, MR600083, MR600084, MR600085, MR600086, MR600087, MR600088, MR600089, MR600090, MR600091, MR600092, MR600093, MR600094, MR600095, MR600096, MR600097, MR600098, MR600099, MR600100, MR600101, MR600102, MR600103, MR600104, MR600105, MR600106, MR600107, MR600108, MR600109, MR600110, MR600111, MR600112, MR600113, MR600114, MR600115, MR600116, MR600117, MR600118, MR600119, MR600120, MR600121, MR600122, MR600123, MR600124, MR600125, MR600126, MR600127, MR600128, MR600129, MR600130, MR600131, MR600132, MR600133, MR600134, MR600135, MR600136, MR600137, MR600138, MR600139, MR600140, MR600141, MR600142, MR600143, MR600144, MR600145, MR600146, MR600147, MR600148, MR600149, MR600150, MR600151, MR600152, MR600153, MR600154, MR600155, MR600156, MR600157, MR600158, MR600159, MR600160, MR600161, MR600162, MR600163, MR600164, MR600165, MR600166, MR600167, MR600168, MR600169, MR600170, MR600171, MR600172, MR600173, MR600174, MR600175, MR600176, MR600177, MR600178, MR600179, MR600180, MR600181, MR600182, MR600183, MR600184, MR600185, MR600186, MR600187, MR600188, MR600189, MR600190, MR600191, MR600192, MR600193, MR600194, MR600195, MR600196, MR600197, MR600198, MR600199, MR600200, MR600201, MR600202, MR600203, MR600204, MR600205, MR600206, MR600207, MR600208, MR600209, MR600210, MR600211, MR600212, MR600213, MR600214, MR600215, MR600216, MR600217, MR600218, MR600219, MR600220, MR600221, MR600222, MR600223, MR600224, MR600225, MR600226, MR600227, MR600228, MR600229, MR600230, MR600231, MR600232, MR600233, MR600234, MR600235, MR600236, MR600237, MR600238, MR600239, and MR600240.
• FEI Number: 3004976058
• Recalling Firm/ Manufacturer: Med-Mizer, Inc.; 80 Commerce Dr; Batesville IN 47006-6700
• For Additional Information Contact: Director of Technical Support and Customer Service; 877-867-7365
• Manufacturer Reason for Recall: Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.
• FDA Determined Cause: Device Design
• Action: Med-Mizer notified distributors of this recall event by distributing an Urgent Medical Device Recall Notice on 02/03/2022 via Certified Mail. The MR600 and STS500 Patient Lifts are being subject to recall due to the potential for the nut securing the boom to become loose over time, which could result in the boom moving unexpectedly side to side or dropping the patient during operation. Customers are asked to inspect all affected devices at their facility to determine if the nut securing the boom is loose. If it is, immediately remove the device from service. Med-Mizer is providing customers with affected devices replacement parts in order to complete the correction. Customers are to complete the provided Correction Response Form to Med-Mizer and return via fax at (812)932-5678, by email at support@med-mizer.com, or by mail at 80 Commerce Drive, Batesville, IN 47006. If your firm is a distributor, please provide this notice to your customers. Any questions can be directed to Med-Mizer by phone at (877)867-7365.
• Quantity in Commerce: 241 units
• Distribution: Awaiting consignee list from the recalling firm.
• 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.