Recall Z-1607-2015— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-03-11, terminated 2018-06-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-11
- Terminated
- 2018-06-26
- Firm location
- Cleveland, OH, United States
Product description
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.
Reason for recall
The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.
Data sourced from openFDA. This site is unofficial and independent of the FDA.