Regulatory UpdatesAug 30, 2026•1 min read

Health Canada Issues Labeling Alert for Pro+ Model p7924a13

By the PharmaCountry team

Health Canada reports that the UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatible bed frame use.

Health Canada has issued an alert regarding the UDI label for model p7924a13. The label incorrectly states the product description as "Pro+ 40 MRS surface with x-ray" instead of the approved "Pro+ 36 MRS surface." The model is intended for 36‑inch width bed frames, not 40‑inch frames. This labeling discrepancy does not match the approved product specifications and could lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame. Users should verify the configuration and ensure the correct bed frame width before use.

Compiled by the PharmaCountry team · Source: Health Canada

Topics:#medical devices #regulatory compliance #UDI #product labeling #patient safety