Date Initiated by Firm | September 22, 2021 |
Create Date | November 24, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0239-2022 |
Recall Event ID |
89023 |
510(K)Number | K202564 |
Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
|
Product | DigitalDiagnost C90 |
Code Information |
DigitalDiagnost C90 |
Recalling Firm/ Manufacturer |
Philips Healthcare 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact | Dusty Leppert 978-228-0190 |
Manufacturer 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. |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
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 DIFCO@philips.com. For questions contact Customer Care Solutions Center 1-800-722-9377. |
Quantity in Commerce | 281 in total |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = MQB
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