FDA Device recall Z-0702-2013
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
- FDA Device
- Class II
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class II recall of Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use by Philips Healthcare, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0702-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-13 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
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
Identifiers
| code_info | Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 1203…Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 : |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0702-2013%22
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