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Terminated

Diagnost 96/97 DSI

FDA Recall Z-1666-2009 · Posted 2009-09-24

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeJAA
Date Initiated2009-07-06
Date Terminated2011-12-16
Product Quantity17 units distributed in US.

Reason for Recall

The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch

Firm Action

A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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