Juno DRF — Class II medical device recall Z-0702-2013
Terminated recall by Philips Healthcare Inc., reported 2013-02-06, distributed nationwide. Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist'
| Recall number | Z-0702-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2012-12-13 |
| Classified | 2013-01-28 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2017-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
| Serial numbers | 10110770, 11030805, 11030806, 11070845, 11070848, 11070849, 11090864, 11110900, 114087, 12020982, 12030999, 12041003, 12061014, 12061018, 12061020, 12081040 |
| Model numbers | 70920 |
Product
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0702-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.