Recalls / —

—#30839

Product

Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K012009

Affected lot / code info

Serial Numbers: 2501 to 2554; 3006; 3008 to 3337.

Why it was recalled

The CT couch may move downward to its lower limit without command.

Root cause (FDA determination)

Other

Action the firm took

The firm contacted their Field Service Personnel by letter on 3/8/2004. The letter instructs the field personnel to immediately install the corrective firmware kits (from Siemens) on all affected units in the field.

Recalling firm

Firm

Philips Medical Systems (Cleveland) Inc

Address

595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern

The systems were installed at medical facilities located nationwide and worldwide.

Timeline

Recall initiated

2004-03-08

Posted by FDA

2004-07-20

Terminated

2008-10-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #30839. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.