Med-Riser MR600 Patient Lift

FDA device recall Z-1204-2023 · posted 2023-03-02 · Open, Classified

Recall details

Recalling firm

Med-Mizer, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

FSA

Quantity affected

241 units

Distribution

Awaiting consignee list from the recalling firm.

Date initiated

2023-02-03

Date posted

2023-03-02

Location

Batesville, IN