Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System
FDA device recall Z-0877-2019 · posted 2019-02-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Nederlands
- Reason for recall
- There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
- Action taken
- Urgent Medical Device Correction notification letters dated December 2018 were sent to customers.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 11226 total
- Distribution
- U.S. Nationwide distribution.
- Date initiated
- 2018-12-21
- Date posted
- 2019-02-22
- Date terminated
- 2020-11-19
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERA FAMILY (K030520) | Philips Medical Systems North America Co. | 2003-03-06 |