ProxiDiagnost N90 is multi-functional general R/F systems.
FDA Recall Z-0240-2022 · Posted None
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Recalling FirmPhilips Healthcare
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2021-09-22
Product Quantity281 in total
Reason for Recall
The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards.
This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification
statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
Firm Action
Philips sent an Electronic Product Radiation Correction letter to inform customers. The letter identified the affected product, problem and actions to be taken. Customers were informed Philips Field Service Engineer will visit their site to check for the required labels and if they are missing, will resolve the issue by applying the required labels. Customers were instructed to complete and return the attached acknowledgment form to Philips DXR via email to [email protected]. For questions contact Customer Care Solutions Center 1-800-722-9377.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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