Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomograp

FDA device recall Z-0067-2014 · posted 2013-10-25 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical.

Action taken

Philips Healthcare sent an Field Safety Notice dated August 16. 3013, via certified mail to all US customers. Market Representative will distribute the letter internationally. The letter identified the product the problem and the action needed to be taken by the customer. Field Safety Notice 88200460 is intended to inform you about; " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. If you need any further information or support concerning these issues, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800.722.9377, option 5: Enter Site ID or follow the prompts).

Root cause

Software design

Status

Terminated

Product code

KPS

Quantity affected

13

Distribution

Worldwide Distribution - US (nationwide) including the states of NY, OH and Pa, and the countries of Australia, Austria, Egypt, France, Germany, India and Netherlands.

Date initiated

2013-08-16

Date posted

2013-10-25

Date terminated

2014-03-26

Location

Cleveland, OH

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