CombiDiagnost R90 1.0 (709030)
FDA device recall Z-1087-2024 · posted 2024-02-14 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Reason for recall
- While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
- Action taken
- An Important Product Notice (2021-PD-DXR-034) dated February 15, 2022 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 follow the provided instructions to ensure there are no pending images before an exam circulate the notice to all users and 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
- Software design
- Status
- Open, Classified
- Product code
- JAA
- Quantity affected
- 86 units
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.
- Date initiated
- 2022-02-11
- Date posted
- 2024-02-14
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Philips CombiDiagnost R90 (K163210) | Philips Medical Systems Dmc GmbH | 2017-01-31 |