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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenuity TF PET/MR

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 Class 2 Device Recall Ingenuity TF PET/MRsee related information
Date Initiated by FirmJuly 23, 2015
Date PostedAugust 31, 2015
Recall Status1 Terminated 3 on June 26, 2018
Recall NumberZ-2491-2015
Recall Event ID 71882
510(K)NumberK103483 
Product Classification Tomographic imager combining emission computed tomography with nuclear magnetic resonance - Product Code OUO
ProductIngenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Code Information M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information ContactMr. Yuchol Kim
440-483-2997
Manufacturer Reason
for Recall		Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.
FDA Determined
Cause 2		Software design
ActionOn July 23, 2015 the firm sent Field Safety Notices to their customers.
Quantity in Commerce11
DistributionProduct was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OUO
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