Recalls / —

—#25965

Product

Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.

FDA product code

KPS — System, Tomography, Computed, Emission

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K882312

Affected lot / code info

All serial numbers of Models N210060 and N210335.

Why it was recalled

The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.

Root cause (FDA determination)

Other

Action the firm took

The firm mailed a ''Customer Advisory Notice'' to all affected customers on 1/23/2003.

Recalling firm

Firm

Philips Medical Systems Inc

Address

595 Miner Rd, Cleveland, Ohio 44143

Distribution

Distribution pattern

The sytems were shipped to end-users located nationwide and worldwide.

Timeline

Recall initiated

2003-01-23

Posted by FDA

2003-02-21

Terminated

2008-10-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25965. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.