GE Healthcare Centricity PACS-IW…

Date

April 11, 2018

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

Product

GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

Reason

A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. 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 indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.

Distribution pattern

Worldwide Distribution-US Nationwide

Quantity

569 units

Codes and lots

Model Numbers: (a) 2052831-00X: Serial Numbers: 4285-1-Centricity PACS-IW-00558123 4479-1-Centricity PACS-IW-00558214 4291-1-Centricity PACS-IW-00558194 4300-1-Centricity PACS-IW-00558207 100701-1-Centricity PACS-IW-00558322 100979-1-Centricity PACS-IW-00558142 4474-1-Centricity PACS-IW-00558169 1153-1-Centricity PACS-IW-00558162 100889-1-Centricity PACS-IW-00558190 100891-1-Centricity PACS-IW-00558184 100892-1-Centricity PACS-IW-00558192 100893-1-Centricity PACS-IW-00558171 100894-1-Centricity PACS-IW-00558200 10994-1-Centricity PACS-IW-00558177 100898-1-Centricity PACS-IW-00558176 100895-1-Centricity PACS-IW-00558195 100823-1-Centricity PACS-IW-00558175 100901-1-Centricity PACS-IW-00558151 100762-1-Centricity PACS-IW-01225872 100902-1-Centricity PACS-IW-00558180 100905-1-Centricity PACS-IW-00558181 100906-1-Centricity PACS-IW-00558165 100908-1-Centricity PACS-IW-00558158 100909-1-Centricity PACS-IW-00558198 100910-1-Centricity PACS-IW-00558178 100911-1-Centricity PACS-IW-00558160 100912-1-Centricity PACS-IW-00558161 100916-1-Centricity PACS-IW-00558199 100917-1-Centricity PACS-IW-00558185 100918-1-Centricity PACS-IW-00558156 4427-1-Centricity PACS-IW-00558113 100919-1-Centricity PACS-IW-00558186 1345-1-Centricity PACS-IW-01225874 100934-1-Centricity PACS-IW-00558201 10683-1-Centricity PACS-IW-00558182 100935-1-Centricity PACS-IW-00558154 100936-1-Centricity PACS-IW-00558153 100938-1-Centricity PACS-IW-00558150 100939-1-Centricity PACS-IW-00558188 100940-1-Centricity PACS-IW-00558173 100943-1-Centricity PACS-IW-00558174 MPX431-Centricity PACS-IW-00044783 RU9038-Centricity PACS-IW-01273313 RU1107-Centricity PACS-IW-01273202 408447-Centricity PACS-IW-00000542 (b) 2049588-008: Serial Numbers: 101039-1-Centricity PACS-IW-00558550 101042-1-Centricity PACS-IW-00558386 100821-1-Centricity PACS-IW-00558325 100674-1-Centricity PACS-IW-00558486 100663-1-Centricity PACS-IW-00558514 101156-1-Centricity PACS-IW-00558446 101181-1-Centricity PACS-IW-00558467 1565-1-Centricity PACS-IW-00603058 101193-1-Centricity PACS-IW-00558551 10884-2-Centricity PACS-IW-00558100 11042-1-Centricity PACS-IW-00558368 101240-1-Centricity PACS-IW-00558425 3571-1-Centricity PACS-IW-00558468 101310-1-Centricity PACS-IW-00558552 101625-1-Centricity PACS-IW-00558531 4684-1-Centricity PACS-IW-00558245 101647-1-Centricity PACS-IW-00558515 4424-1-Centricity PACS-IW-00558429 101171-1-Centricity PACS-IW-00558310 101689-1-Centricity PACS-IW-00558326 101883-1-Centricity PACS-IW-00558487 101932-1-Centricity PACS-IW-00558495 101792-1-Centricity PACS-IW-00558370 101742-1-Centricity PACS-IW-00558470 4734-1-Centricity PACS-IW-00558375 4424-1-Centricity PACS-IW-00558429 4573-1-Centricity PACS-IW-00558420 4353-1-Centricity PACS-IW-00558273 4256-1-Centricity PACS-IW-00558250 4553-1-Centricity PACS-IW-00558327 100802-1-Centricity PACS-IW-00558540 100489-1-Centricity PACS-IW-00558547 4482-1-Centricity PACS-IW-00558281 13064-2-Centricity PACS-IW-00558102 4211-1-Centricity PACS-IW-00558277 4694-1-Centricity PACS-IW-00558556 9754-1-Centricity PACS-IW-00558490 4593-1-Centricity PACS-IW-00558488 100702-1-Centricity PACS-IW-00558539 4110-1-Centricity PACS-IW-00558409 2481-1-Centricity PACS-IW-00558524 100769-1-Centricity PACS-IW-00558427 4707-1-Centricity PACS-IW-00558434 4276-1-Centricity PACS-IW-00558274 13175-1-Centricity PACS-IW-00558383 4345-1-Centricity PACS-IW-00558548 100468-1-Centricity PACS-IW-00558330 12931-1-Centricity PACS-IW-00558419 4269-1-Centricity PACS-IW-00558252 100458-1-Centricity PACS-IW-00558538 4357-1-Centricity PACS-IW-00558444 100806-1-Centricity PACS-IW-00558441 9978-3-Centricity PACS-IW-00558108 4262-1-Centricity PACS-IW-00558544 4277-1-Centricity PACS-IW-00558474 4497-1-Centricity PACS-IW-00558497 100104-1-Centricity PACS-IW-00558403 4359-1-Centricity PACS-IW-00558410 100972-1-Centricity PACS-IW-00558278 4450-1-Centricity PACS-IW-00558319 100199-1-Centricity PACS-IW-00558503 4583-1-Centricity PACS-IW-00558246 13162-1-Centricity PACS-IW-00558365 4361-1-Centricity PACS-IW-00558343 4362-1-Centricity PACS-IW-00558395 4363-1-Centricity PACS-IW-00558374 4282-1-Centricity PACS-IW-00558414 13102-1-Centricity PACS-IW-00558512 4354-1-Centricity PACS-IW-00558519 4284-1-Centricity PACS-IW-00558453 4157-1-Centricity PACS-IW-00558516 13225-1-Centricity PACS-IW-00558553 4551-1-Centricity PACS-IW-00558508 3640-1-Centricity PACS-IW-00558511 4287-1-Centricity PACS-IW-00558117 4290-1-Centricity PACS-IW-00558217 12968-1-Centricity PACS-IW-00558506 4366-1-Centricity PACS-IW-00558542 13265-1-Centricity PACS-IW-00558482 4660-1-Centricity PACS-IW-00558288 13372-1-Centricity PACS-IW-00558309 4294-1-Centricity PACS-IW-00558379 3545-1-Centricity PACS-IW-00558239 4539-1-Centricity PACS-IW-00558378 3943-1-Centricity PACS-IW-00558501 13039-1-Centricity PACS-IW-00558385 4367-1-Centricity PACS-IW-00558415 4368-1-Centricity PACS-IW-00558513 4296-1-Centricity PACS-IW-00558477 12967-1-Centricity PACS-IW-00558555 100065-1-Centricity PACS-IW-00558317 100862-1-Centricity PACS-IW-00558349 4299-1-Centricity PACS-IW-00558545 4615-1-Centricity PACS-IW-00558333 4372-1-Centricity PACS-IW-00558523 100835-1-Centricity PACS-IW-00558287 2035-1-Centricity PACS-IW-00558411 13295-1-Centricity PACS-IW-00558346 4305-1-Centricity PACS-IW-00558337 4301-1-Centricity PACS-IW-00558525 100770-1-Centricity PACS-IW-00558097 4495-1-Centricity PACS-IW-00558476 13197-1-Centricity PACS-IW-00558251 4374-1-Centricity PACS-IW-00558422 100664-1-Centricity PACS-IW-00558437 100582-1-Centricity PACS-IW-00558530 4676-1-Centricity PACS-IW-00558449 4456-1-Centricity PACS-IW-00558295 13345-1-Centricity PACS-IW-00558641 100852-1-Centricity PACS-IW-00558494 13232-1-Centricity PACS-IW-00558348 4376-1-Centricity PACS-IW-00558399 100666-1-Centricity PACS-IW-00558465 13233-1-Centricity PACS-IW-00558554 100729-1-Centricity PACS-IW-00558455 4358-1-Centricity PACS-IW-00558564 4744-1-Centricity PACS-IW-00558373 4378-1-Centricity PACS-IW-00558498 4585-1-Centricity PACS-IW-00558335 4379-1-Centricity PACS-IW-00558496 100581-1-Centricity PACS-IW-00558505 4668-1-Centricity PACS-IW-00558529 13095-1-Centricity PACS-IW-00558534 9764-1-Centricity PACS-IW-00558394 4614-1-Centricity PACS-IW-00558393 1475-1-Centricity PACS-IW-00558558 12830-1-Centricity PACS-IW-00558312 4382-1-Centricity PACS-IW-00558396 4383-1-Centricity PACS-IW-00558533 4321-1-Centricity PACS-IW-00558371 100717-1-Centricity PACS-IW-00558517 13360-1-Centricity PACS-IW-00558263 9791-1-Centricity PACS-IW-00558418 10749-1-Centricity PACS-IW-00558509 10750-1-Centricity PACS-IW-00558536 10749-1-Centricity PACS-IW-00558509 10750-1-Centricity PACS-IW-00558536 100645-1-Centricity PACS-IW-00558408 2387-1-Centricity PACS-IW-00558489 12902-1-Centricity PACS-IW-00558461 100580-1-Centricity PACS-IW-00558339 12974-1-Centricity PACS-IW-00558300 13209-1-Centricity PACS-IW-00558357 4552-1-Centricity PACS-IW-00558510 13164-1-Centricity PACS-IW-00558439 12821-1-Centricity PACS-IW-00558526 101216-1-Centricity PACS-IW-00558356 100009-1-Centricity PACS-IW-00558560 4387-1-Centricity PACS-IW-00558493 4326-4-Centricity PACS-IW-00558105 12966-1-Centricity PACS-IW-00558481 4460-1-Centricity PACS-IW-00558562 4542-1-Centricity PACS-IW-00558430 4682-1-Centricity PACS-IW-00558270 4506-1-Centricity PACS-IW-00558345 4328-1-Centricity PACS-IW-00558518 4430-1-Centricity PACS-IW-00558500 4389-1-Centricity PACS-IW-00558563 13134-1-Centricity PACS-IW-00558492 101598-1-Centricity PACS-IW-00667133 4531-1-Centricity PACS-IW-00558376 4681-1-Centricity PACS-IW-00558431 100166-1-Centricity PACS-IW-00558448 100881-1-Centricity PACS-IW-00558546 1402-1-Centricity PACS-IW-00558291 3189-1-Centricity PACS-IW-00558314 4391-1-Centricity PACS-IW-00558502 100191-1-Centricity PACS-IW-00558541 4487-1-Centricity PACS-IW-00558559 4128-1-Centricity PACS-IW-00558234 10467-1-Centricity PACS-IW-00558405 4351-1-Centricity PACS-IW-00558485 2337-1-Centricity PACS-IW-00558363 4179-1-Centricity PACS-IW-00558543 4393-1-Centricity PACS-IW-00558328 4268-1-Centricity PACS-IW-00558416 4611-1-Centricity PACS-IW-00558362 4264-1-Centricity PACS-IW-00558254 10250-1-Centricity PACS-IW-00558504 100811-1-Centricity PACS-IW-00558535 100761-1-Centricity PACS-IW-00558527 4262-1-Centricity PACS-IW-00558507 100636-1-Centricity PACS-IW-00558521 4311-1-Centricity PACS-IW-00558321 9844-1-Centricity PACS-IW-00558332 4350-1-Centricity PACS-IW-00558301 4393-1-Centricity PACS-IW-00558565 4273-1-Centricity PACS-IW-01225873 4285-1-Centricity PACS-IW-00558567 100835-1-Centricity PACS-IW-00558568 4313-1-Centricity PACS-IW-00558566 102206-1-Centricity PACS-IW-00558447 9094-1-Centricity PACS-IW-01805004 115-Centricity PACS-IW-01288657 ONCOLOGY-Centricity PACS-IW-01288658 85021-Centricity PACS-IW-00006698 06002-Centricity PACS-IW-00115199 00001-Centricity PACS-IW-00164412 529010-Centricity PACS-IW-00000342 651948-Centricity PACS-IW-00000422 941804-Centricity PACS-IW-00000474 150010-Centricity PACS-IW-00000213 YP5673-Centricity PACS-IW-00045220 FP5028-Centricity Universal Viewer-00110911 YP3150-Centricity PACS-IW-00045222 YP3150-Centricity PACS-IW-00045224 UP506-Centricity PACS-IW-00044759 ZA2501-Centricity PACS-IW-00162756 ZA2315-Centricity PACS-IW-00111417 ZA2372-Centricity PACS-IW-00111415 ZA2401-Centricity PACS-IW-00116562 ZA2402-Centricity PACS-IW-00116561 ZA2474-Centricity PACS-IW-00116763 ZA2338-Centricity PACS-IW-00116588 ZA2339-Centricity PACS-IW-00116589 ZA2409-Centricity PACS-IW-00116591 ZA2408-Centricity PACS-IW-00116590 ZA2410-Centricity PACS-IW-00116592 ZA2414-Centricity PACS-IW-00116438 ZA2415-Centricity PACS-IW-00116440 ZA2353-Centricity PACS-IW-00116567 ZA2471-Centricity PACS-IW-00116573 ZA2351-Centricity PACS-IW-00116569 ZA2470-Centricity PACS-IW-00116572 ZA2352-Centricity PACS-IW-00116570 ZA2267-Centricity PACS-IW-00116765 ZA2356-Centricity PACS-IW-00116576 ZA2355-Centricity PACS-IW-00116575 ZA2336-Centricity PACS-IW-00116448 ZA2331-Centricity PACS-IW-00116443 ZA2335-Centricity PACS-IW-00116447 ZA2330-Centricity PACS-IW-00116442 ZA2334-Centricity PACS-IW-00116446 SI4014-Centricity PACS-IW-00038786 SA2235-Centricity PACS-IW-00038164 SA2128-Centricity PACS-IW-00065800 SA2402-Centricity PACS-IW-00347384 SA2191-Centricity PACS-IW-00065833 SA2221-Centricity PACS-IW-00065837 SA2315-Centricity PACS-IW-00038176 SA 1175-Centricity PACS-IW-00065872 SA2294-Centricity PACS-IW-00065843 SA 2281-Centricity PACS-IW-00065865 SA 1025-Centricity PACS-IW-00065854 SA1126-Centricity PACS-IW-00065887 SA2187-Centricity PACS-IW-00065875 SA1198-Centricity PACS-IW-00065868 SA1052-Centricity PACS-IW-00065793 SA1175-Centricity PACS-IW-00038187 SA2281-Centricity PACS-IW-00038161 600100-Centricity PACS-IW-01273193 RU1241-Centricity PACS-IW-01273216 RU1493-Centricity PACS-IW-01273220 RU2967-Centricity PACS-IW-01273244 RU5302-Centricity PACS-IW-01273274 RU2420-Centricity PACS-IW-01273234 RU3910-Centricity PACS-IW-01273270 RU3262-Centricity PACS-IW-01273245 RU6248-Centricity PACS-IW-01273279 RU1648-Centricity PACS-IW-01273222 RU8071-Centricity PACS-IW-01273295 RU6340-Centricity PACS-IW-01273280 RU8041-Centricity PACS-IW-01273294 RU7576-Centricity PACS-IW-01273287 RU3880-Centricity PACS-IW-01273266 RU3894-Centricity PACS-IW-01273269 RU3564-Centricity PACS-IW-01273252 RU8162-Centricity PACS-IW-01273299 RU2527-Centricity PACS-IW-01273235 RU5310-Centricity PACS-IW-01273276 RU3959-Centricity PACS-IW-01273273 RU2878-Centricity PACS-IW-01273243 RU1050-Centricity PACS-IW-00167296 RU8370-Centricity PACS-IW-01273306 RU3572-Centricity PACS-IW-01273255 RU6340-Centricity PACS-IW-01273282 RU8953-Centricity PACS-IW-01273311 600160-Centricity PACS-IW-01273191 RU3625-Centricity PACS-IW-01273258 RU5499-Centricity PACS-IW-01273278 RU3680-Centricity PACS-IW-01273260 RU3382-Centricity PACS-IW-01273247 RU3380-Centricity PACS-IW-01273246 RU1469-Centricity PACS-IW-01273219 RU1199-Centricity PACS-IW-01273215 RU1028-Centricity PACS-IW-01273197 RU1717-Centricity PACS-IW-01273225 RU9000-Centricity PACS-IW-01273312 RU1857-Centricity PACS-IW-01273229 RU8219-Centricity…

Recall started

Feb. 23, 2018

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

GE Healthcare sent an Urgent Medical Device Correction letter dated February 23, 2018 to their customers. The letter provided the affected product, problem and provided the following safety instructions: "Until a product modification is available to correct this issue, the following actions are recommended: 1. Utilize the image count within the QC process to alert the user of a discrepancy in the number of transmitted images from the modality to the number of images available in the Universal Viewer. a. If a discrepancy is identified, attempt to retransmit the exam to PACS. b. If retransmission is unsuccessful, a GE Healthcare Service representative will need to be contacted to assist with resolution of the impacted exam. Urgent cases impacted by this issue should be interpreted at the modality. 2. If DICOM storage commit is configured and in use, no commit notification is sent to the modality for images that were impacted by this issue. 3. Attention should be given to prior cases, acquired before the application of the safety instructions given in this communication as they may be affected by the safety issue." If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recall number

Z-1302-2018

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

Source: FDA · Medical device enforcement report, recall number Z-1302-2018. The agency record governs; check it and the company before acting.