FDA Device recall Z-0362-2017
Symbiq Two Channel Infuser
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of Symbiq Two 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-0362-2017 |
| 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 Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. 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 | 14589022 14589046 14589066 14589083 14589108 14589117 14589154 14589165 14589169 14589172 14589232 14589235…14589022 14589046 14589066 14589083 14589108 14589117 14589154 14589165 14589169 14589172 14589232 14589235 14589264 14589276 14589277 14589293 14589321 14589328 14589346 14589382 14589399 14589431 14589451 14589587 14589642 14589692 14589696 14589720 14589721 14589733 14589761 14589779 14589792 14589802 14590003 14590023 14590035 14590117 14590153 14590279 14590287 14590315 14590324 14590409 14590436 14590445 14590469 14590484 14590507 14590526 14590527 14590531 14590542 14590544 14590548 14590568 14590582 14590677 14590687 14590693 14590736 14590796 14590830 14590877 14590905 14590947 14590956 14591038 14591080 14591081 14591182 14591210 14591386 14591406 14591442 14591460 14591473 14591496 14591500 14591518 14591574 14591583 14591599 14591632 14591634 14591672 14591673 14591678 14591696 14591697 14591723 14591741 14591760 14591761 14591762 14591773 14591783 14591815 14591819 14591820 |
|---|
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-0362-2017%22
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