Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cle

FDA device recall Z-1598-2015 · posted 2015-05-12 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

KPS

Quantity affected

918 units

Distribution

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

Date initiated

2015-03-13

Date posted

2015-05-12

Date terminated

2018-06-26

Location

Cleveland, OH

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