Intera 1.5T Power/Pulsar
FDA device recall Z-0394-2024 · posted 2023-11-21 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- Potential component failure in the Gradient Coil could product smoke and/or fire.
- Action taken
- The firm mailed URGENT Medical Device Correction Notices dated 10/23/2023 to consignees to notify them of this recall event. Consignees are instructed to identify if they possess any affected devices in their inventory and to follow the provided instructions for when scan aborts occur to prevent the failure mode associated with this recall event. Consignees are to stop the scan immediately and contact Philips Service if any of the failure situations outlined in the notice occur during a scan. Consignees are asked to complete and return the provided response form to Philips no later than 30 days after receipt of the recall notice. Questions can be directed to Customer Care Solutions at 1-800-722-9377.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LNH
- Quantity affected
- 1 unit
- Distribution
- Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denm
- Date initiated
- 2023-10-23
- Date posted
- 2023-11-21
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 (K162931) | Philips Medical Systems Nederland B.V. | 2017-01-06 |