Known Identifiers & Locations
FEI Numbers
3002806395
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0019-2015 |
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.
|
2014-03-17 |
Terminated
|
View Details
|
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