FDA · Medical device recall

The Centricity PACS-IW with Universal Viewer is a device that… and 1 more product

Nov. 11, 2015 Class II

Date: Nov. 11, 2015
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
Reason: Inaccurate distance measurements with magnified projection X-ray images.
Distribution pattern: Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.

2 products in this recall

The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms)…

Product: The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Quantity: Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units
Codes and lots: 2067131-001DVD UNIVERSAL VIEWER 5.0 - WEB CLIENT
Recall started: Sept. 28, 2015
Device type: System, Image Processing, Radiological
Root cause (FDA): Software design
What the company told customers: An URGENT MEDICAL DEVICE CORRECTION letter was sent to all medical users on 9/28/2015 regarding Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer- Inaccurate distance measurements with magnified projection X-ray images. GE Healthcare explains that for all projection X-rays, GE Healthcare recommends that the user perform the necessary measurements on the standard contact images, and not rely on measurements made on the magnified views unless the measurements have been independently verified for each X-Ray machine installed or manually calibrated using a radio-opaque fiducial of a known size. 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. GE Healthcare will correct all affected systems by providing a software update at no cost to the customer. GE Healthcare advises customers if they have any questions or concerns regarding the notification, to please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Recall number: Z-0225-2016

The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and…

Product: The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Quantity: Centricity Universal Viewer versions 6.0 and higher 5 units
Codes and lots: 2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT
Recall started: Sept. 28, 2015
Device type: System, Image Processing, Radiological
Root cause (FDA): Software design
What the company told customers: An URGENT MEDICAL DEVICE CORRECTION letter was sent to all medical users on 9/28/2015 regarding Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer- Inaccurate distance measurements with magnified projection X-ray images. GE Healthcare explains that for all projection X-rays, GE Healthcare recommends that the user perform the necessary measurements on the standard contact images, and not rely on measurements made on the magnified views unless the measurements have been independently verified for each X-Ray machine installed or manually calibrated using a radio-opaque fiducial of a known size. 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. GE Healthcare will correct all affected systems by providing a software update at no cost to the customer. GE Healthcare advises customers if they have any questions or concerns regarding the notification, to please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Recall number: Z-0226-2016

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0225-2016, Z-0226-2016. The agency record governs; check it and the company before acting.

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