FDA Device recall Z-0451-2016
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digi…
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digi… by Shimadzu Medical Systems, citing the firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0451-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-10 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Shimadzu Medical Systems |
| Distribution | n/a |
Product
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
Reason
The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
Identifiers
| code_info | Serial No. 41DBBB534001 41DBBB534004 41DBBB534002 41DBBB534005 41DBBB534006 41DBBB536001 41DBBB536007 41DBBB536…Serial No. 41DBBB534001 41DBBB534004 41DBBB534002 41DBBB534005 41DBBB534006 41DBBB536001 41DBBB536007 41DBBB536008 41DBBB536009 41DBBB536010 41DBBB539001 41DBBB539002 41DBBB539003 41DBBB539004 41DBBB53A001 M1DBBB547001 M1DBBB547002 M1DBBB547003 M1DBBB547004 M1DBBB547005 M1DBBB547006 M1DBBB547007 M1DBBB548001 M1DBBB548002 41DBBA136010 41DBBA136014 41DBBA145008 41DBBA145009 41DBBA145016 41DBBA141006 41DBBA147004 41DBBA149021 41DBBA149022 41DBBA132003 41DBBA142001 41DBBA14A004 41DBBA132001 41DBBA132010 41DBBA141012 41DBBA142012 41DBBA147017 41DBBA147028 41DBBA146015 41DBBA146017 41DBBA142004 41DBBA142014 41DBBA148002 41DBBA131018 41DBBA131020 41DBBA136006 41DBBA136011 41DBBA141013 41DBBA14A010 41DBBA142019 41DBBA142020 41DBBA149005 41DBBA145024 41DBBA143002 41DBBA141009 41DBBA136003 41DBBA136004 41DBBA132002 41DBBA146021 41DBBA146028 41DBBA14A007 41DBBA141001 41DBBA142015 41DBBA146002 41DBBA147008 41DBBA14A015 41DBBA |
|---|
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-0451-2016%22
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