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Terminated

Philips Omni Diagnost Eleva

FDA Recall Z-0911-2007 · Posted 2007-09-25

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIZI
Date Initiated2007-07-23
Date Terminated2012-09-17
Product Quantity14 units

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.

K032046PHILLIPS OMNIDIAGNOST ELEVAPhilips Medical Systems, Inc. · 2003-07-17

Official Source

View FDA Recall →

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

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