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Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mamm...

FDA Device Recall #Z-0375-2019 — Class II — October 11, 2018

Recall Summary

Recall Number Z-0375-2019
Classification Class II — Moderate risk
Date Initiated October 11, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Healthcare, LLC
Location Waukesha, WI
Product Type Devices
Quantity 73

Product Description

Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.

Reason for Recall

Synchronization failure

Distribution Pattern

CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.

Lot / Code Information

06051-Centricity Universal Viewer-00115203 06051PAC04; 102278-1-Centricity Universal Viewer-00558682 1-644600677; 102359-1-Centricity Universal Viewer-00558696 1-473998727; 102406-2-Centricity Universal Viewer-00558111 1-661827397; 102406-2-Centricity Universal Viewer-00558686 1-750710672; 102406-2-Centricity Universal Viewer-00558692 1-682147792; 102406-2-Centricity Universal Viewer-00558707 1-802428413; 103090-2-Centricity Universal Viewer-00546048 303715CVUWTSW; 104336-1-Centricity Universal Viewer-00346858 918277CVUWBSW; 13296-1-Centricity Universal Viewer-01364047 LCSH01364047; 1472-15-Centricity Universal Viewer-01367676 210875CAUVSW; 190171-Centricity Universal Viewer-00044015 190171ST05; 2440-1-Centricity Universal Viewer-00558701 PACS-IW-150; 282927-Centricity Universal Viewer-01806769 416813TESTRPACSUV; 300013-Centricity Universal Viewer-00156933 300013ST22; 329052-Centricity Universal Viewer-01443407 HCIT4270016UV; 339734-Centricity PACS-IW-01444878 HCIT4114402PIW;¿ 34381-Centricity Universal Viewer-00116124 34381PAC04; 34381-Centricity Universal Viewer-01980265 Installation tracked via Service Cloud Installed Product ID.; 4271-1-Centricity Universal Viewer-00558351 PACS-IW-129; 4289-1-Centricity Universal Viewer-00558459 PACS-IW-352; 4325-51-Centricity Universal Viewer-00599129 1-592001096; 4325-51-Centricity Universal Viewer-00599129 1-592001096; 4406-1-Centricity Universal Viewer-00558683 PACS-IW-323; 4491-1-Centricity Universal Viewer-00558690 PACS-IW-253; 48010-Centricity Universal Viewer-01444602 48010PAC04; 53008-Centricity Universal Viewer-00116118 53008PAC03; 81111-Centricity Universal Viewer-01286673 81111DBS01; 899010-Centricity Universal Viewer-01300907 Installation tracked via Service Cloud Installed Product ID.; 899010-Centricity Universal Viewer-01300907 Installation tracked via Service Cloud Installed Product ID.; 9752-1-Centricity Universal Viewer-00558454 PACS-IW-288; 9796-1-Centricity Universal Viewer-00558571 1-368083413; A54120-Centricity Universal Viewer-00040449 A5412010; A54852-Centricity Universal Viewer-00043560 A5485262 / A5485266 / A5485267 / A5485269 / A5485270 / A5485271; A91901-Centricity Universal Viewer-00044549 A9190177; A91901-Centricity Universal Viewer-01509889 A9190177; AMS39-Centricity Universal Viewer-00545606 AMS3963; AMS39-Centricity Universal Viewer-00545606 AMS3963; BON01-Centricity Universal Viewer-00044131 BON0164; ECT02-Centricity Universal Viewer-00059842 ECT0265; FP5028-Centricity Universal Viewer-00110911 FP502804; GH1077-Centricity Universal Viewer-01724675 GH1077UV01 Installation tracked via System ID. 4435495-1 Installation tracked via System ID. HCIT4270016UV¿ Installation tracked via System ID. HN-NA¿ Installation tracked via System ID. HCIT4220435UV Installation tracked via System ID. HCIT4264206UW¿; M15393-Centricity Universal Viewer-00043611 M1539319 / M1539321 / M1539322; M232471-Centricity Universal Viewer-00043629 M23247104; M41870-Centricity Universal Viewer-00043721 M4187019 /M4187021 / M4187022; M41913-Centricity Universal Viewer-00065993 M4191318 / M4191319; M41980-Centricity Universal Viewer-00044515 M41980107; M42073-Centricity Universal Viewer-00044530 M4207315; M42176-Centricity Universal Viewer-00043763 M4217634 / M4217636 / M4217628; M42176-Centricity Universal Viewer-00043763 M4217634 / M4217636 / M4217628; M44599-Centricity Universal Viewer-00043784 M4459914 / M4459916 / M4459917; M44875-Centricity Universal Viewer-00043829 M4487535; M44877-Centricity Universal Viewer-00043766 M4217637 / M4487710; M44997-Centricity Universal Viewer-00397920 M44997011; M45006-Centricity Universal Viewer-00043854 M4500623 / M4500625 / M4500626; PL1124-Centricity Universal Viewer-00038795 PL1124RW01; PL2970-Centricity Universal Viewer-00038797 PL2970RW01; PL3249-Centricity Universal Viewer-00038866 PL3249RW02; PL3277-Centricity Universal Viewer-00038831 PL3277RW01; PX4900-Centricity Universal Viewer-01369835 PX4900SV02; SA1339-Centricity Universal Viewer-00116444 Installation tracked via Service Cloud Installed Product ID; X1413856-Centricity Universal Viewer-00044474 X141385617; X1982342-Centricity Universal Viewer-00043950 X198234211 / X198234210; X3141198-Centricity Universal Viewer-00043959 X314119802; YP3150-Centricity Universal Viewer-01639018 Installation tracked via Service Cloud Installed Product ID.; ZA00113-Centricity Universal Viewer-01474463 ZA2990PP02; ZA1058-Centricity Universal Viewer-01724673 ZA1058UV01; and ZA2551-Centricity Universal Viewer-00116834 ZA2551PAC1.

Other Recalls from GE Healthcare, LLC

Recall # Classification Product Date
Z-1566-2022 Class II (1) GE Centricity Universal Viewer 6.0, Model 2... Jul 15, 2022
Z-1430-2022 Class II SIGNA Premier magnetic resonance scanner, model... Jun 24, 2022
Z-1466-2022 Class II Centricity PACS Software Version 7.0 SP0.0.4.7 Jun 14, 2022
Z-1333-2022 Class II GE Centricity Universal Viewer Zero Footprint. ... Jun 8, 2022
Z-1511-2022 Class II Service manuals for the CT, PET, or NM table as... Jun 2, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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