Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System.
FDA device recall Z-1826-2014 · posted 2014-06-18 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
- Action taken
- Philips sent an Urgent Field Safety Notice (FSN78100414) dated May 2014 via certified mail to US and Canadian consignees. Philips Key Market representatives will distribute the letter internationally. The letter identified the affected product, explains the problem, actions that should be taken in order to prevent risks for users, and the actions planned by Philips to correct the problem. On May 31, 2014, Philips released a Field Change Order that requires service engineers to replace the front and rear covers of the Ingenia MR FlexTrak Trolley with new covers with protection bumper that prevents foot clamping. For further information and support concerning this issue, consignees should contact their local Philips representative at 1-800-722-9377.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 420
- Distribution
- Worldwide Distribution - US (nationwide), Canada, Mexico Australia, Austria, Germany, Belarus, Bulgaria, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Jordan, Korea, Republ
- Date initiated
- 2014-05-15
- Date posted
- 2014-06-18
- Date terminated
- 2015-08-07
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T (K110151) | Philips Health Care | 2011-03-22 |