Recalls / —

—#27872

Product

Easy Access PACS System with software Release 5, 6.2, or 7.2

FDA product code

LLZ — System, Image Processing, Radiological

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K983447

Affected lot / code info

To be provided

Why it was recalled

Potential display of an incorrect body part description on patient images.

Root cause (FDA determination)

Other

Action the firm took

On 2/13/02 the firm issued a letter to their consignees. The letter provided a remedy to the situtaion.

Recalling firm

Firm

Philips Medical Systems

Address

22100 Bothell Everett Highway, Bothell, Washington 98041

Distribution

Distribution pattern

The firm distributed units to 46 hospitals and medical centers located throughout the U.S.

Timeline

Recall initiated

2002-02-13

Posted by FDA

2003-09-12

Terminated

2005-04-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.