Recall StatusTerminated
Date Initiated2015-03-13
Date Terminated2018-06-26
Product Quantity918 units
Reason for Recall
During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.
Firm Action
Philips sent an Customer Information letter dated March 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to :
1. Do not lubricate the clutch(es) with oil, grease or any other type of lubricant..
2. Follow product Instructions For Use (IFU), CARDIO. SOLUS, ADAC VERTEX, AND ADAC VERTEX PLUS WITH ATLAS USERS MANUAL, 9201-0227E-ENG, REV A- General Precautions that instructs user to monitor the patient during scanning.
3. Follow product Instructions For Use (IFU), CARDIC, SOLUS, ADAC VERTEX, AND ADAC VERTEX PLUS WITH ATLAS USER'SMANUAL, 9201-0227E-ENG, REV A- Emergency Patient Removal, Section Safety and Regulatory Agency Compliance, page 2-11, instruction(s) on emergency
patient removal.
4. Ensure completion of product Preventive Maintenance (PM) procedure requiring inspection of the radius drive clutches every 3 months for contamination and replacement if contaminated and, testing of the gantry system.
If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
Distribution Pattern
Worldwide Distribution - US (nationwide) including Puerto Rico and to the states of : AL, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Costa Rica, Denmark, Egypt, France, Germany, Ireland, Italy, Japan, Lebanon, Malaysia, Netherlands, Norway, Pakistan, Portugal, Republic of Korea, Russia, South Korea, Spain, Sweden, Syrian Arab Republic, Thailand and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.