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Terminated

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

FDA Recall Z-0563-03 · Posted 2003-02-21

Recalling FirmPhilips Medical Systems Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2003-01-23
Date Terminated2008-10-29
Product Quantity311 units

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K882312MODEL 3000 NUCLEAR CAMERAOhio Imaging, Inc. · 1988-07-14

Official Source

View FDA Recall →

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

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