Medtronic Neuromodulation: SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B

Hazard

Software issues were identified in application version 2.x.

Details from the source

Reason for recall: Software issues were identified in application version 2.x. Distribution: Worldwide - US Nationwide distribution. Quantity: 319 systems Lot/code info: GTIN: 00643169890947, 00763000447090; Serial Numbers: NPL1000037 NPL1000042 NPL1000045 NPL1000048 NPL1000051 NPL1000054 NPL1000055 NPL1000056 NPL1000062 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000078 NPL1000083 NPL1000092 NPL1000093 NPL1000094 NPL1000096 NPL1000098 NPL1000132 NPL1000151 NPL1000159 NPL1000161 NPL1000165 NPL1000166 NPL1000173 NPL1000174 NPL1000179 NPL1000180 NPL1000185 NPL1000186 NPL1000189 NPL1000191 NPL1000195 NPL1000196 NPL1000230 NPL1000233 NPL1000238 NPL1000239 NPL1000249 NPL1000257 NPL1000281 NPL1000297 NPL1000301 NPL1000303 NPL1000321 NPL1000323 NPL1000325 NPL1000331 NPL1000334 NPL1000343 NPL1000344 NPL1000361 NPL1000363 NPL1000367 NPL1000370 NPL1000486 NPL1000501 NPL1000504 NPL1000505 NPL1000506 NPL1000507 NPL1000509 NPL1000510 NPL1000515 NPL1000516 NPL1000518 NPL1000519 NPL1000528 NPL1000555 NPL1000556 NPL1000558 NPL1000561 NPL1000562 NPL1000563 NPL1000571 NPL1000573 NPL1000574 NPL1000584 NPL1000585 NPL1000592 NPL1000603 NPL1000606 NPL1000612 NPL1000627 NPL1000630 NPL1000631 NPL1000632 NPL1000634 NPL1000638 NPL1000639 NPL1001196 NPL1001209 NPL1001212 NPL1001214 NPL1001216 NPL1001228 NPL1001235 NPL1001236 NPL1001237 NPL1001241 NPL1001243 NPL1001245 NPL1001247 NPL1001249 NPL1001252 NPL1001259 NPL1001260 NPL1001265 NPL1001273 NPL1001277 NPL1001292 NPL1001293 NPL1001294 NPL1001296 NPL1001297 NPL1001298 NPL1001301 NPL1001304 NPL1001314 NPL1001323 NPL1001324 NPL1001325 NPL1001328 NPL1001330 NPL1001332 NPL1001333 NPL1001336 NPL1001337 NPL10

UPC codes

00643169890947, 00763000447090

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.