CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report
Ingenuity TF PET/MR, Diagnostic Imaging System recalled
Philips Medical Systems (Cleveland) is recalling Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems, distributed in New York, Ohio, Texas. The recall was initiated on 23 Jul 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2491-2015
- FDA event ID
- 71882
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jul 2015
- FDA classified
- 31 Aug 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 23 Jul 2015 | Recall initiated by company | |
| 31 Aug 2015 | Classified by FDA | +39 days |
| 9 Sep 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Where it was distributed
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.
Questions about this recall
Why was it 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 lots are affected?
M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems (Cleveland)
All 315| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pinnacle Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Device Malfunction | Nationwide |
| Device | CLASS II | Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Device Malfunction | Nationwide |
| Device | CLASS II | Pinnacle3 Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Other | 21 states |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |