Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Reported: September 9, 2015 Initiated: July 23, 2015 #Z-2491-2015
Product Description
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
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.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 11
- Distribution
- Product 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.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 11.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 9, 2015. Severity: Moderate. Recall number: Z-2491-2015.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11