—#192099

Product

Compella Bariatric Bed System

FDA product code: IOQ — Bed, Flotation Therapy, Powered
Device class: Class 2
Medical specialty: Physical Medicine
Affected lot / code info: All lots/serial numbers UDI information: Compella Bariatric Bed - 00887761000902

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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 acknowledgment form and confirm that they read and understand the issue. Distributors will be asked to forward to their end users. Distributors will be provided instruction on communication with their end users.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: 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, Poland, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkmenistan, UAE, and UK.

Timeline

Recall initiated: 2022-02-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192099. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.