—#188909

Product

Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123174
Affected lot / code info: 2068177-001 (Centricity PACS-IW with Universal Viewer software versions 5.0.x with PACS-IW foundation) System ID: 083055248481416, 1-121967267, 1-429329281, DGC19607785, HC3062UV01, HCIT1401012UW, HCIT4331279UV, PACS-IW-127, PACS-IW-219, PACS-IW-2770, PACS-IW-323, PACS-IW-421, RICHMONDU14767331, RICHMONDU15531177N1, X1347906 / X1347909, X1347906 / X1347909, YP315021, ZA2412PAC21 and ZA2533PAC1

Why it was recalled

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

Root cause (FDA determination)

Software design

Action the firm took

This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 06, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change. 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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: AK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV and WY. Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom and Uruguay.

Timeline

Recall initiated: 2021-08-06
Posted by FDA: 2021-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188909. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.