Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general us
FDA device recall Z-0702-2013 · posted 2013-01-28 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21
- Action taken
- Philips Medical issued a notification by letter dated December 13, 2012. via Certified Mail to affected customer. The letter identified the affected product, problem and actions to be taken. Philips will contact affected customers to schedule an upgrade of the equipment . For questions or support concerning this issue, please contact Dominic Siewko at 978-659-7936.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- RCA
- Quantity affected
- 16 units
- Distribution
- US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA
- Date initiated
- 2012-12-13
- Date posted
- 2013-01-28
- Date terminated
- 2017-01-24
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APOLLO (K050190) | Villa Sistemi Medicali S.P.A. | 2005-03-25 |