FDA Device recall Z-2107-2012

Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 400…

FDA Device
Class I
terminated
Published 2012-08-08

On 2012-08-08 the FDA classified a Class I recall of Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 400… by Smiths Medical Asd, citing smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm.….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2107-2012
Classification	Class I
Status	terminated
Initiated	2012-02-14
Published	2012-08-08
Last updated	2026-09-13 11:53 UTC
Company	Smiths Medical Asd
Distribution	CA

Product

Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

Reason

Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.

Identifiers

code_info	2000245 2000246 2000247 2000248 2000249 2000250 2000251 2000252 2000253 2000254 2000255 2000256 2000257 20… 2000245 2000246 2000247 2000248 2000249 2000250 2000251 2000252 2000253 2000254 2000255 2000256 2000257 2000258 2000259 2000260 2000261 2000262 2000263 2000264 2000265 2000266 2000267 2000268 2000269 2000270 2000271 2000272 2000273 2000274 2000275 2000276 2000277 2000278 2000279 2000280 2000281 2000282 2000283 2000284 2000285 2000286 2000287 2000288 2000289 2000290 2000291 2000292 2000293 2000294 2000295 2000296 2000297 2000298 2000299 2000300 2000301 2000302 2000303 2000304 2000305 2000307 2000308 2000309 2000310 2000311 2000312 2000313 2000314 2000315 2000316 2000317 2000318 2000319 2000320 2000321 2000322 2000323 2000324 2000325 2000326 2000327 2000328 2000329 2000330 2000331 2000332 2000333 2000334 2000336 2000337 2000338 2000339 2000340 2000341 2000342 2000343 2000344 2000345 2000346 2000347 2000348 2000349 2000350 2000351 2000352 2000353 2000354 2000355 2000356 2000357 2

code_info

2000245 2000246 2000247 2000248 2000249 2000250 2000251 2000252 2000253 2000254 2000255 2000256 2000257 20…

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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-2107-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.