FDA Device recall Z-0353-2017
Symbiq One Channel Infuser
- FDA Device
- Class II
- terminated
- Published 2016-11-09
On 2016-11-09 the FDA classified a Class II recall of Symbiq One 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-0353-2017 |
| 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 One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
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: 14339017 14339062 14339063 14339066 14339071 14339072 14339076 14339078 14339079 14339084…Serial Numbers: 14339017 14339062 14339063 14339066 14339071 14339072 14339076 14339078 14339079 14339084 14339086 14339087 14339089 14339090 14339091 14339095 14339097 14339098 14339099 14339102 14339104 14339105 14339107 14339108 14339111 14339113 14339114 14339115 14339116 14339119 14339121 14339125 14339128 14339130 14339133 14339136 14339138 14339139 14339140 14339141 14339142 14339145 14339146 14339149 14339150 14339152 14339154 14339155 14339158 14339168 14339171 14339172 14339179 14339180 14339185 14339190 14339192 14339194 14339195 14339200 14339201 14339205 14339216 14339228 14339230 14339231 14339233 14339236 14339243 14339246 14339248 14339250 14339251 14339254 14339262 14339271 14339274 14339280 14339283 14339287 14339291 14339293 14339299 14339302 14339304 14339308 14339322 14339327 14339328 14339344 14339346 14339348 14339349 14339351 14339358 14339359 14339361 14339362 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-0353-2017%22
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