Recall Z-0325-2016— Philips Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-08-21, terminated 2021-05-12. It names 2 FDA 510(k) clearances: K110151, K063559. Product: 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.. Reason: 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..
- Recalling firm
- Philips Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-21
- Terminated
- 2021-05-12
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K110151 — ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
- K063559 — ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.