Recall record at a glance
| Official record | Z-0325-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips Medical Systems, Inc. |
| Report date | Dec 2, 2015 |
| Recall initiation date | Aug 21, 2014 |
| Quantity | 307 units |
| Location | Andover, MA, United States |
Official product description
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
Why the product was recalled
When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8.
Distribution information
Worldwide Distribution - USA (nationwide) and to the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Denmark Estonia, Ethiopia. France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic of, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Palestinian territory, Peru, Poland, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates and United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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