Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
FDA device recall Z-1054-2024 · posted 2024-02-08 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Reason for recall
- A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
- Action taken
- An Urgent Medical Device Correction notice (2023-PD-CTAMI-017) dated December 13, 2023 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- US: 1
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany,
- Date initiated
- 2023-12-13
- Date posted
- 2024-02-08
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Spectral CT on Rails (K212875) | Philips Medical Systems Nederland B.V. | 2022-05-13 |