FDA Device recall Z-0354-2017
Symbiq Two Channel Infuser
- FDA Device
- Class II
- terminated
- Published 2016-11-09
On 2016-11-09 the FDA classified a Class II recall of Symbiq Two Channel Infuser by Hospira, citing hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Su….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0354-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-05 |
| Published | 2016-11-09 |
| 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; Product List Number 16027
Reason
Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.
Identifiers
| code_info | Serial Numbers: 14589003 14589008 14589009 14589012 14589013 14589014 14589015 14589017 14589020 14589022…Serial Numbers: 14589003 14589008 14589009 14589012 14589013 14589014 14589015 14589017 14589020 14589022 14589028 14589030 14589031 14589033 14589034 14589035 14589043 14589046 14589048 14589049 14589050 14589053 14589057 14589060 14589063 14589064 14589066 14589068 14589072 14589078 14589082 14589083 14589086 14589092 14589095 14589100 14589101 14589105 14589108 14589110 14589111 14589116 14589117 14589118 14589121 14589127 14589131 14589133 14589135 14589136 14589137 14589139 14589140 14589141 14589144 14589148 14589149 14589151 14589154 14589159 14589160 14589161 14589162 14589165 14589167 14589169 14589172 14589174 14589175 14589178 14589180 14589188 14589195 14589203 14589204 14589206 14589214 14589215 14589221 14589222 14589225 14589228 14589230 14589231 14589232 14589233 14589235 14589237 14589241 14589245 14589248 14589252 14589257 14589258 14589259 14589260 14589264 14589265 1 |
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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-0354-2017%22
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