Recall Z-2376-2016— Hill-Rom, Inc.
Class II · Terminated
Class II FDA medical device recall by Hill-Rom, Inc., initiated 2016-06-14, terminated 2017-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.. Reason: The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To date there has been one report of a related injury..
- Recalling firm
- Hill-Rom, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-14
- Terminated
- 2017-05-15
- Firm location
- Batesville, IN, United States
Product description
Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.
Reason for recall
The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To date there has been one report of a related injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.