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Med-Riser MR600 Patient Lift recallZ-1204-2023 · Med-Mizer, Inc. · initiated Feb 3, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Med-Mizer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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 [email protected], 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.

Recall details

Recall number
Z-1204-2023
Status
Open, Classified
Initiated by the company
Feb 3, 2023
Posted by the FDA
Mar 2, 2023
Recalling firm
Med-Mizer, Inc.
Quantity
241 units
Product code
FSA
Distribution
Awaiting consignee list from the recalling firm.

Product description

Med-Riser MR600 Patient Lift

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 91695).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page