GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1…

Date

June 19, 2019

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

Reason

There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.

Distribution pattern

Worldwide

Quantity

620 units

Codes and lots

a) 2052831-00x, Lot or Serial Numbers: 100839-1-Centricity PACS-IW-00558122 100893-1-Centricity PACS-IW-00558171 4320-1-Centricity PACS-IW-00558202 4474-1-Centricity PACS-IW-00558169 2455-1-Centricity PACS-IW-00558139 100863-1-Centricity PACS-IW-00558143 100794-1-Centricity PACS-IW-00558193 4346-1-Centricity PACS-IW-00558136 100909-1-Centricity PACS-IW-00558198 4355-1-Centricity PACS-IW-00558204 100809-1-Centricity PACS-IW-00558124 4300-1-Centricity PACS-IW-00558207 4484-1-Centricity PACS-IW-00558213 4479-1-Centricity PACS-IW-00558214 13240-2-Centricity PACS-IW-01225875 4270-1-Centricity PACS-IW-00558129 11059-2-Centricity PACS-IW-00558101 101598-1-Centricity PACS-IW-00667133 4273-1-Centricity PACS-IW-01225873 4357-1-Centricity PACS-IW-00558444 4293-1-Centricity PACS-IW-00558131 100835-1-Centricity PACS-IW-00558568 100900-1-Centricity PACS-IW-00558170 4344-1-Centricity PACS-IW-00558196 3836-1-Centricity PACS-IW-00558179 4428-1-Centricity PACS-IW-00558205 100609-1-Centricity PACS-IW-00558130 4297-1-Centricity PACS-IW-00558134 100975-1-Centricity PACS-IW-00558137 100667-1-Centricity PACS-IW-00558163 4316-1-Centricity PACS-IW-00558210 4251-1-Centricity PACS-IW-00558120 4254-1-Centricity PACS-IW-00558211 100981-1-Centricity PACS-IW-00558132 100871-1-Centricity PACS-IW-00558146 2553-1-Centricity PACS-IW-00558206 4283-1-Centricity PACS-IW-00558187 4469-1-Centricity PACS-IW-00558128 100020-1-Centricity PACS-IW-00558147 4443-1-Centricity PACS-IW-00558167 4317-1-Centricity PACS-IW-00558208 100775-1-Centricity PACS-IW-00558209 4323-1-Centricity PACS-IW-00558164 100825-1-Centricity PACS-IW-00558172 100830-1-Centricity PACS-IW-00558166 4304-1-Centricity PACS-IW-00558145 4721-1-Centricity PACS-IW-00558138 4104-1-Centricity PACS-IW-00558133 4292-1-Centricity PACS-IW-00558203 100980-1-Centricity PACS-IW-00558140 4343-1-Centricity PACS-IW-00558115 4298-1-Centricity PACS-IW-00558116 4252-1-Centricity PACS-IW-00558119 4287-1-Centricity PACS-IW-00558117 4291-1-Centricity PACS-IW-00558194 100978-1-Centricity PACS-IW-00558141 4448-1-Centricity PACS-IW-00558118 100979-1-Centricity PACS-IW-00558142 100865-1-Centricity PACS-IW-01225871 100807-1-Centricity PACS-IW-00558121 100807-1-Centricity PACS-IW-00558212 4424-1-Centricity PACS-IW-00558429 339142-Centricity PACS-IW-01431503 13759-Centricity PACS-IW-01431508 320090-Centricity PACS-IW-01444604 320092-Centricity PACS-IW-01444618 297958-Centricity PACS-IW-01444903 329997-Centricity PACS-IW-01444898 AiKang-Centricity PACS-IW-01824737 SiteID-Centricity PACS-IW-01572187 SiteID-Centricity PACS-IW-01797297 339734-Centricity PACS-IW-01444878 313825-Centricity PACS-IW-01444348 332562-Centricity PACS-IW-01444345 338295-Centricity PACS-IW-01443383 SiteID-Centricity PACS-IW-01444354 SiteID-Centricity PACS-IW-02003770 276233-Centricity PACS-IW-01444355 331973-Centricity PACS-IW-01434505 279961-Centricity PACS-IW-01444358 SiteID-Centricity PACS-IW-00161903 SiteID-Centricity PACS-IW-00161906 186588-Centricity PACS-IW-01461366 SiteID-Centricity PACS-IW-02095351 RU9038-Centricity PACS-IW-01273313 RU1107-Centricity PACS-IW-01273202 MPX431-Centricity PACS-IW-00044783 b) 2050578-0xx Lot or Serial Numbers: 100664-1-Centricity PACS-IW-00558437 100639-1-Centricity PACS-IW-00558450 4261-1-Centricity PACS-IW-00558480 101587-1-Centricity PACS-IW-00558369 4614-1-Centricity PACS-IW-00558393 4376-1-Centricity PACS-IW-00558399 4436-1-Centricity PACS-IW-00558417 4350-13-Centricity PACS-IW-00558296 4680-1-Centricity PACS-IW-00558360 100666-1-Centricity PACS-IW-00558465 101171-1-Centricity PACS-IW-00558310 101792-1-Centricity PACS-IW-00558370 4264-1-Centricity PACS-IW-00558254 4286-1-Centricity PACS-IW-00558361 4284-1-Centricity PACS-IW-00558453 4605-1-Centricity PACS-IW-00558350 4446-2-Centricity PACS-IW-00558106 4280-1-Centricity PACS-IW-00558240 12830-1-Centricity PACS-IW-00558312 100580-1-Centricity PACS-IW-00558339 100858-1-Centricity PACS-IW-00558426 100674-1-Centricity PACS-IW-00558315 102206-1-Centricity PACS-IW-00558447 4684-1-Centricity PACS-IW-00558245 4256-1-Centricity PACS-IW-00558250 4707-1-Centricity PACS-IW-00558434 100783-1-Centricity PACS-IW-00558255 4263-1-Centricity PACS-IW-00558279 100970-1-Centricity PACS-IW-00558303 4689-1-Centricity PACS-IW-00558242 100767-1-Centricity PACS-IW-00558377 100766-1-Centricity PACS-IW-00558355 100764-1-Centricity PACS-IW-00558452 100765-1-Centricity PACS-IW-00558331 4350-1-Centricity PACS-IW-00558301 4350-1-Centricity PACS-IW-00558307 4350-1-Centricity PACS-IW-00558318 4350-1-Centricity PACS-IW-00558432 4109-1-Centricity PACS-IW-00558389 4485-1-Centricity PACS-IW-00558479 100485-1-Centricity PACS-IW-00558258 100759-1-Centricity PACS-IW-00558268 4687-1-Centricity PACS-IW-00558334 1005-1-Centricity PACS-IW-00558282 1005-1-Centricity PACS-IW-00558290 100836-1-Centricity PACS-IW-00558256 4311-1-Centricity PACS-IW-00558321 100757-1-Centricity PACS-IW-00558261 4679-1-Centricity PACS-IW-00558412 100718-1-Centricity PACS-IW-00558424 13332-1-Centricity PACS-IW-00558390 4294-1-Centricity PACS-IW-00558379 13360-1-Centricity PACS-IW-00558263 12908-1-Centricity PACS-IW-00558302 4359-1-Centricity PACS-IW-00558410 13039-1-Centricity PACS-IW-00558385 100166-1-Centricity PACS-IW-00558448 9757-1-Centricity PACS-IW-00558247 1412-1-Centricity PACS-IW-00558228 4274-1-Centricity PACS-IW-00558436 100156-1-Centricity PACS-IW-00558243 100156-1-Centricity PACS-IW-00558475 4723-1-Centricity PACS-IW-00558367 4539-1-Centricity PACS-IW-00558378 101042-1-Centricity PACS-IW-00558386 3189-1-Centricity PACS-IW-00558314 4495-1-Centricity PACS-IW-00558476 4734-1-Centricity PACS-IW-00558375 100701-1-Centricity PACS-IW-00558322 100722-1-Centricity PACS-IW-00558407 2035-1-Centricity PACS-IW-00558411 101742-1-Centricity PACS-IW-00558470 104648-2-Centricity PACS-IW-00558406 4670-1-Centricity PACS-IW-00558329 100855-1-Centricity PACS-IW-00558298 4385-1-Centricity PACS-IW-00558336 4260-1-Centricity PACS-IW-00558244 100065-1-Centricity PACS-IW-00558317 4295-1-Centricity PACS-IW-00558341 13209-1-Centricity PACS-IW-00558357 4676-1-Centricity PACS-IW-00558449 13295-1-Centricity PACS-IW-00558346 9791-1-Centricity PACS-IW-00558418 4273-1-Centricity PACS-IW-01225873 4269-1-Centricity PACS-IW-00558252 100589-1-Centricity PACS-IW-00558384 13337-1-Centricity PACS-IW-00558401 13337-1-Centricity PACS-IW-00558478 100876-1-Centricity PACS-IW-00558440 11764-1-Centricity PACS-IW-00558388 101689-1-Centricity PACS-IW-00558326 9764-1-Centricity PACS-IW-00558394 100835-1-Centricity PACS-IW-00558287 100831-1-Centricity PACS-IW-00558232 4744-1-Centricity PACS-IW-00558373 100772-1-Centricity PACS-IW-00558269 4281-1-Centricity PACS-IW-00558354 12960-1-Centricity PACS-IW-00558289 9978-3-Centricity PACS-IW-00558108 1402-1-Centricity PACS-IW-00558291 4321-1-Centricity PACS-IW-00558371 4381-1-Centricity PACS-IW-00558423 1451-1-Centricity PACS-IW-00558294 13175-1-Centricity PACS-IW-00558383 10467-1-Centricity PACS-IW-00558405 10911-1-Centricity PACS-IW-00558471 100821-1-Centricity PACS-IW-00558325 4425-1-Centricity PACS-IW-00558472 4268-1-Centricity PACS-IW-00558416 9844-1-Centricity PACS-IW-00558332 9767-1-Centricity PACS-IW-00558265 4305-1-Centricity PACS-IW-00558337 4367-1-Centricity PACS-IW-00558415 4128-1-Centricity PACS-IW-00558234 101098-1-Centricity PACS-IW-00558387 4322-1-Centricity PACS-IW-00558285 4352-1-Centricity PACS-IW-00558316 4374-1-Centricity PACS-IW-00558422 100827-1-Centricity PACS-IW-00558233 4360-1-Centricity PACS-IW-00558237 4335-1-Centricity PACS-IW-00558267 4349-1-Centricity PACS-IW-00558284 4211-1-Centricity PACS-IW-00558277 3545-1-Centricity PACS-IW-00558239 10527-3-Centricity PACS-IW-00558344 4348-1-Centricity PACS-IW-00558458 4362-1-Centricity PACS-IW-00558395 4576-1-Centricity PACS-IW-00558306 10916-1-Centricity PACS-IW-00558299 4288-1-Centricity PACS-IW-00558235 4266-1-Centricity PACS-IW-00558304 100511-1-Centricity PACS-IW-00558549 1565-1-Centricity PACS-IW-00603058 4277-1-Centricity PACS-IW-00558474 4553-1-Centricity PACS-IW-00558327 101216-1-Centricity PACS-IW-00558356 4531-1-Centricity PACS-IW-00558376 101240-1-Centricity PACS-IW-00558425 100021-1-Centricity PACS-IW-00558260 4660-1-Centricity PACS-IW-00558288 2481-1-Centricity PACS-IW-00558381 4447-1-Centricity PACS-IW-00558398 4078-1-Centricity PACS-IW-00558462 100806-1-Centricity PACS-IW-00558441 4361-1-Centricity PACS-IW-00558343 13164-1-Centricity PACS-IW-00558439 4504-1-Centricity PACS-IW-00558438 4413-1-Centricity PACS-IW-00558433 4416-1-Centricity PACS-IW-00558292 4416-1-Centricity PACS-IW-00558293 4417-1-Centricity PACS-IW-00558364 4419-1-Centricity PACS-IW-00558483 4420-1-Centricity PACS-IW-00558404 100378-1-Centricity PACS-IW-00558238 4508-1-Centricity PACS-IW-00558271 100603-1-Centricity PACS-IW-00558266 10462-1-Centricity PACS-IW-00558272 12953-1-Centricity PACS-IW-00558443 10483-1-Centricity PACS-IW-00558098 1331-1-Centricity PACS-IW-00558451 12949-1-Centricity PACS-IW-00558442 4296-1-Centricity PACS-IW-00558477 100088-1-Centricity PACS-IW-00558320 4351-1-Centricity PACS-IW-00558485 1584-1-Centricity PACS-IW-00558297 1173-1-Centricity PACS-IW-00558473 4450-1-Centricity PACS-IW-00558319 100972-1-Centricity PACS-IW-00558278 4276-1-Centricity PACS-IW-00558274 101647-1-Centricity PACS-IW-00558515 11711-2-Centricity PACS-IW-00558262 4542-1-Centricity PACS-IW-00558430 13265-1-Centricity PACS-IW-00558482 12974-1-Centricity PACS-IW-00558300 100770-1-Centricity PACS-IW-00558097 100769-1-Centricity PACS-IW-00558427 4393-1-Centricity PACS-IW-00558328 13372-1-Centricity PACS-IW-00558309 13197-1-Centricity PACS-IW-00558251 11042-1-Centricity PACS-IW-00558368 100468-1-Centricity PACS-IW-00558330 4575-1-Centricity PACS-IW-00558342 12931-1-Centricity PACS-IW-00558419 4482-1-Centricity PACS-IW-00558281 4568-1-Centricity PACS-IW-00558280 3571-1-Centricity PACS-IW-00558468 100645-1-Centricity PACS-IW-00558408 100771-1-Centricity PACS-IW-00558249 4632-1-Centricity PACS-IW-00558311 4681-1-Centricity PACS-IW-00558431 4573-1-Centricity PACS-IW-00558420 100729-1-Centricity PACS-IW-00558455 4456-1-Centricity PACS-IW-00558295 4506-1-Centricity PACS-IW-00558345 BA4080-Centricity PACS-IW-00038769 324462-Centricity PACS-IW-01431554 293035-Centricity PACS-IW-01401532 280801-Centricity PACS-IW-01431490 335279-Centricity PACS-IW-01431638 306930-Centricity PACS-IW-01401530 296619-Centricity PACS-IW-01401506 330917-Centricity PACS-IW-01401529 SiteID-Centricity PACS-IW-01422991 313741-Centricity PACS-IW-01422998 238110-Centricity PACS-IW-01431521 246838-Centricity PACS-IW-01421153 134265-Centricity PACS-IW-01431539 307319-Centricity PACS-IW-01444609 230048-Centricity PACS-IW-01442018 SiteID-Centricity PACS-IW-01444879 209545-Centricity PACS-IW-01460552 EG1856-Centricity PACS-IW-00118541 EG1009-Centricity PACS-IW-00118535 EG1871-Centricity PACS-IW-00118532 EG1905-Centricity PACS-IW-00117725 EG1771-Centricity PACS-IW-00118550 EG1858-Centricity PACS-IW-00118544 EG1808-Centricity PACS-IW-00118538 EG1857-Centricity PACS-IW-00118547 M41678-Centricity PACS-IW-00043697 M41741-Centricity PACS-IW-00043705 M42172-Centricity PACS-IW-00165182 683198-Centricity PACS-IW-00000826 600791-Centricity PACS-IW-00000776 UHAM02-Centricity PACS-IW-00001927 RMUE01-Centricity PACS-IW-00001801 PC0125-Centricity PACS-IW-00001683 HU1025-Centricity PACS-IW-00038776 HU1469-Centricity PACS-IW-00038785 HU1038-Centricity PACS-IW-00038778 HU1093-Centricity PACS-IW-00038784 HU1397-Centricity PACS-IW-00038782 HU1185-Centricity PACS-IW-00038781 HU1433-Centricity PACS-IW-00038783 HU1008-Centricity PACS-IW-00038775 HU1036-Centricity PACS-IW-00038777 HU1041-Centricity PACS-IW-00038780 HU1039-Centricity PACS-IW-00038779 ApolloBSR-Centricity PACS-IW-01819452 StThomas-Centricity PACS-IW-01819447 HOLY-FAMILY-THODU-Centricity PACS-IW-01821493 SODANI-Centricity PACS-IW-01819445 WOCKHARDT-Centricity PACS-IW-01819449 DAKE-Centricity PACS-IW-01819448 SIMS-Centricity PACS-IW-01819453 MARTHANDAM-Centricity PACS-IW-01819446 CTSI-Centricity PACS-IW-01819444 CONTINENTAL-Centricity…

Recall started

May 22, 2019

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

The firm initiated their medical device correction by letter on 05/2/2019. The letter explained the problem and the safety issue and provided the following safety instructions: 1) Process Root Causes: Investigation determined that the original PACS-IW foundation design did not incorporate adequate risk mitigation for this part of the image ingestion process. DFMEA of the image ingestion wing to wing process was completed as part of the investigation, and no additional areas where further mitigations are required were identified. a) If a discrepancy is identified, attempt to retransmit the exam to PACS. b) If retransmission is unsuccessful, contact a GE Healthcare Service representative for assistance in resolving the impacted exam. c) Urgent cases impacted by this issue should be interpreted by the clinician at the modality. 2) Be aware that if DICOM storage commit is configured and in use, the modality will not be sent a commit notification for images impacted by this issue. 3) Attention should be given to prior cases, acquired before the application of the safety instructions given in this communication, because they may be affected by this issue. For historical data inquiries, please contact a GE Healthcare service representative for assistance in identifying any affected images. The units will be upgraded.

Recall number

Z-1781-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1781-2019. The agency record governs; check it and the company before acting.