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Terminated

MD3 X-ray system

FDA Recall Z-0851-06 · Posted 2006-05-06

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeJAA
Date Initiated2006-04-06
Date Terminated2008-05-21
Product Quantity37units

Reason for Recall

Potential for unexpected table movement.

Firm Action

On 4/6/06 the firm issued a letter to consignees advising of the problem. The letter advises consignees to conduct a test on their unit(s) for a possible short until the firm is able to upgrade the units.

Root Cause

Other

Distribution Pattern

Units were distributed to hospitals and medical centers located throughou the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K904012PHILIPS INTEGRIS I 2000 SYSTEMPhilips Medical Systems, Inc. · 1990-11-29

Official Source

View FDA Recall →

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

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