TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and Accu...
FDA Device Recall #Z-1794-2013 — Class II — May 30, 2013
Recall Summary
| Recall Number | Z-1794-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 30, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hill-Rom, Inc. |
| Location | Batesville, IN |
| Product Type | Devices |
| Quantity | 4,121 Units |
Product Description
TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Reason for Recall
When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A patient attempting to get back into the bed may miss the seat and sit on the foot section instead. The patient can slide down to the floor, or fall, with possible injury.
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Canada, Colombia, Nigeria, Kuwait and Saudi Arabia.
Lot / Code Information
Bed model numbers: PAU001010784, PAU005010784, P1900, PAK169N10184, PAK169N10384, PA8171210184, PA8175210184, PA8175210384, PA8171210384, PA8171310384, and PA8173210384. The AccuMax Quantum VPC, Complete and Convertible mattresses are not serialized, but were distributed between September 2005 and April 2013
Other Recalls from Hill-Rom, Inc.
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|---|---|---|---|
| Z-0783-2022 | Class II | (1)Traverse Rail Carrier E-System, wide 31017XX... | Jan 14, 2022 |
| Z-0639-2022 | Class II | Liko Mobile Lifts: Primarily intended for use i... | Dec 23, 2021 |
| Z-0640-2022 | Class II | Liko Mobile Lifts: Primarily intended for use i... | Dec 23, 2021 |
| Z-2600-2021 | Class II | LikoStretch 1900 Model Number: 3156051 - The co... | Aug 11, 2021 |
| Z-2599-2021 | Class II | Stretch Leveller Model Number: 3156200 - The co... | Aug 11, 2021 |
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.