PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 20, 2015 Initiated: March 11, 2015 #Z-1607-2015

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.

Details

Units Affected
975 units
Distribution
Worldwide Distribution - US (nationwide) to the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of : Australia, Austria, Belgium, Brazil, Canada, China, Costa Rica, Egypt, France, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Lebanon, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, South Korea, Spain,Thailand and United Kingdom.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 975 units.
Why was this product recalled?
The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 20, 2015. Severity: Moderate. Recall number: Z-1607-2015.