FDA Device recall Z-2682-2016
Philips DuraDiagnost stationary X-ray system
- FDA Device
- Class II
- terminated
- Published 2016-09-07
On 2016-09-07 the FDA classified a Class II recall of Philips DuraDiagnost stationary X-ray system by Philips Electronics North America, citing buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2682-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-17 |
| Published | 2016-09-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | CA, ME, NC, NE, OH, OR, TX, WA |
Product
Philips DuraDiagnost stationary X-ray system
Reason
Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
Identifiers
| code_info | SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2682-2016%22
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