Recall Z-0820-2022 ยท IOQ Bed, Flotation Therapy, Powered
Baxter Healthcare Corporation
Compella Bariatric Bed System
| Date | Feb 14, 2022 |
| Status | Terminated |
| Reason | Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains. |
| Root cause | Labeling design |
| Action | Customer notification letters were mailed beginning 02/21/2022. A localized customer letter will be mailed (with signature service) to all first-level consignees by Sedgwick. The letter will inform the customer of the issue, reason for Field Action and provide risk mitigations. The customer will be instructed to sign acknowledgement form to confirm receipt and return to a dedicated email address. Distributors will be asked to forward to their end users. Distributors will be provided with instructions on communication with their end users. All consignees will be required to return a signed |
| Quantity | 5186 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Jamaica, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.