Philips Digital Diagnost X-Ray system
FDA Recall Z-0908-2007 · Posted 2007-09-25
Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeMQB
Date Initiated2007-07-23
Date Terminated2012-09-17
Product Quantity6 units + 227 units added = 233
Reason for Recall
Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.
Firm Action
On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.
Root Cause
Other
Distribution Pattern
Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
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.