Philips Multi Diagnost Eleva with FlatDetector
FDA device recall Z-1045-2015 · posted 2015-02-26 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
- Action taken
- Philips Healthcare Planned Action: 1. Software updates to SW R6.1.3 through Field Change Orders (FCOs) FCO70800140 and FCO70800142. 2. A customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Philips Healthcare will implement this CAP by September 1, 2015. For further questions please call (978) 687-1501.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 238
- Distribution
- Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Aust
- Date initiated
- 2013-10-14
- Date posted
- 2015-02-26
- Date terminated
- 2017-01-23
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIDIAGNOST ELEVA (K050151) | Philips Medical Systems North America, Inc. | 2005-02-09 |