CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report
Ingenuity TF PET/CT - a integrated diagnostic X-ray recalled
Philips Medical Systems (Cleveland) is recalling Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron. The recall was initiated on 1 Nov 2017 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-0522-2018
- FDA event ID
- 79004
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2017
- FDA classified
- 4 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 1 Nov 2017 | Recall initiated by company | |
| 4 Feb 2018 | Classified by FDA | +95 days |
| 14 Feb 2018 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Product as listed by the FDA
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Where it was distributed
One domestic and 1 foreign consignee ( Spain)
Questions about this recall
Why was it recalled?
One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Which lots are affected?
Ingenuity TF PET/CT Model # 882442
Where was it sold?
One domestic and 1 foreign consignee ( Spain)
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.
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