Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1607-2015 — Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

U.S. FDA — Device Enforcement · United States · 2015-03-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1607-2015
Date of alert: 2015-03-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems (Cleveland) Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 802080322

Reported risk: The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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