Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed

FDA device recall Z-1646-2012 · posted 2012-05-22 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Software errors. A number of non-conformances were identified and corrected by Philips Medical for their Ingenuity TF PET/MRI Systems running software version 3.7.1. The firm states that these non-conformances stemmed from software and/or documentation errors, and that software corrections are being performed in order to 'improve the overall quality and functionality of the Ingenuity TF CT/MRI S

Action taken

The firm, Philips Medical, sent an 'URGENT - Medical Device Correction' notification letter dated April 13, 2012 to all affected customers via Certified mail. The letter informs the customers of the firm's upcoming software update. It tells the customers that the software for the Ingenuity TF PET/MR system unit will be upgraded from version 3.7.1 to version 3.7.2 and that the update/upgrade will provide a number of improvements to the overall quality and functionality of the Ingenuity TF PET/MR System. The notification document states that Philips will be installing the system update to version 3.7.2 software through a Field Change Order. This will be implemented free-of-charge and will include complementary PET/MR application training. For further information, call toll-free telephone number which they can call 1-800-722-9377 and follow the menu options to reach a Customer Solutions Engineer.

Root cause

Software design

Status

Terminated

Product code

OUO

Quantity affected

8units (2 units in U.S. & 6 units in other countries)

Distribution

Worldwide distribution: USA (nationwide) including states of: OH and NY; and countries of: China, Finland, Germany, South Korea, Spain, and Switzerland.

Date initiated

2012-04-13

Date posted

2012-05-22

Date terminated

2013-08-05

Location

Cleveland, OH

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