RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Lo...
FDA Device Recall #Z-1542-2014 — Class II — April 18, 2014
Recall Summary
| Recall Number | Z-1542-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 18, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Med-Mizer, Inc. |
| Location | Batesville, IN |
| Product Type | Devices |
| Quantity | 1 |
Product Description
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
Reason for Recall
All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on th
Distribution Pattern
USA (nationwide)
Lot / Code Information
Serial Number 2000
Other Recalls from Med-Mizer, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1205-2023 | Class II | Sit to Stand STS500 Patient Lift | Feb 3, 2023 |
| Z-1204-2023 | Class II | Med-Riser MR600 Patient Lift | Feb 3, 2023 |
| Z-3183-2018 | Class II | PR1000 Pivot Rehab Bed AC powered adjustable bed. | Jul 25, 2018 |
| Z-1541-2014 | Class II | RetractaBed , Clinical Contour, Med - Mizer Inc... | Apr 18, 2014 |
| Z-1543-2014 | Class II | RetractaBed , Clinical Contour, Med - Mizer Inc... | Apr 18, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.