Recall Z-0019-2015— Arjo Hospital Equipment AB
Class II · Terminated
Class II FDA medical device recall by Arjo Hospital Equipment AB, initiated 2014-03-17, terminated 2018-02-14. FDA's recall record names no specific 510(k) clearance for this event. Product: ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.. Reason: There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40..
- Recalling firm
- Arjo Hospital Equipment AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-17
- Terminated
- 2018-02-14
- Firm location
- Eslov, Sweden
Product description
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Reason for recall
There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40.
Data sourced from openFDA. This site is unofficial and independent of the FDA.