Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. T
FDA device recall Z-1682-2015 · posted 2015-05-28 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data.
- Action taken
- On 3/11/2015 the firm sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected device, explained the reason for the recall, how to identify affected product, advice on actions to be taken by customer/user, and any actions planned by the firm. Customers were advised to use software provided by Philips to view spectroscopy images; and, not to export and view images using third party software. The firm stated that it will be issuing a software update. If further information or support concerning the issue is needed, customers are asked to contact their local Philips representative or local Philips Healthcare office.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution -- US, including the states of NY, OH, & TX; and, the countries of Finland, Germany, Japan, Netherlands, South Korea, Spain, & Switzerland.
- Date initiated
- 2015-03-11
- Date posted
- 2015-05-28
- Date terminated
- 2018-06-26
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INGENUITY TF PET/MR (K103483) | Philips Healthcare (Cleveland) | 2011-11-23 |