Philips DuraDiagnost stationary X-ray system

FDA device recall Z-2682-2016 · posted 2016-09-01 · Terminated

Recall details

Recalling firm

Philips Electronics North America Corporation

Reason for recall

Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].

Action taken

Philips plans to bring the products into compliance with the Federal standard at no cost to customers by implementing a field correction. 1. You will contact customers and initiate the actions to correct the failure to comply issues. 2. You will attach the warning label to maintain an audible volume, and issue a supplement to the user manual that instructs the user how to adjust the volume for the local noise environment and include a warning that the user shall maintain an audible volume. 3. You will attach the identification label to the affected Height-Adjustable Tabletop. 4. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. If you need any further information or support concerning this, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

KPR

Quantity affected

15

Distribution

US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.

Date initiated

2015-09-17

Date posted

2016-09-01

Date terminated

2017-08-31

Location

Andover, MA

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