Health Canada has issued a product alert concerning the UDI label of medical device model p7924a13. The label incorrectly describes the product as "Pro+ 40 MRS surface with x‑ray," whereas the approved configuration is "Pro+ 36 MRS surface." Consequently, the device should be paired with 36‑inch width bed frames, not 40‑inch frames. This labeling discrepancy does not match the authorized product specifications and could lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
法规动态2026年8月30日•1 分钟阅读
Health Canada issues alert on Pro+ model p7924a13 labeling error
The UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatibility with bed frames.
由 PharmaCountry 团队整理 · 来源： Health Canada
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