FDA Device recall Z-0361-2017
Symbiq One Channel Infuser
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of Symbiq One Channel Infuser by Hospira, citing may go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0361-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-03-16 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hospira |
| Distribution | US |
Product
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Reason
May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.
Identifiers
| code_info | 14339017 14339063 14339071 14339076 14339078 14339084 14339086 14339087 14339091 14339095 14339097 14339104…14339017 14339063 14339071 14339076 14339078 14339084 14339086 14339087 14339091 14339095 14339097 14339104 14339105 14339108 14339114 14339115 14339119 14339125 14339130 14339140 14339142 14339145 14339146 14339149 14339158 14339171 14339172 14339192 14339195 14339200 14339271 14339283 14339304 14339308 14339322 14339327 14339328 14339344 14339358 14339359 14339362 14339367 14339369 14339370 14339377 14339380 14339384 14339389 14339391 14339392 14339396 14339407 14339411 14339413 14339414 14339415 14339422 14339424 14339426 14339504 14339517 14339519 14339524 14339529 14339534 14339545 14339569 14339572 14339664 14339669 14339681 14339723 14339789 14339849 14339905 14339921 14339932 14339933 14339985 14339987 14339989 14339990 14340000 14340002 14340004 14340006 14340008 14340017 14340027 14340038 14340039 14340041 14340048 14340053 14340058 14340060 14340063 14340065 14340067 14340071 |
|---|
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-0361-2017%22
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