FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
- Recall number
- Z-0702-2013
- Recalling firm
- Philips Healthcare Inc.
- Product
- Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
- Status
- Terminated
- Initiated
- 2012-12-13
- Posted
- 2013-01-28
- Terminated
- 2017-01-24
- Reason
- 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
- Root cause
- Radiation Control for Health and Safety Act
- Action
- 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.
- Quantity
- 16 units
- Distribution
- US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA
- Lot, serial or model codes
- Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 :
- 510(k) numbers
- ["K050190"]
- PMA numbers
- not on file
- Product code
- RCA
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28