Class II Recall

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3

Summary

The FDA issued a Class II for (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Uni by GE Healthcare, LLC. Reason: Inaccurate Distance and Area measurements with use of Global Stack viewport..

Details

Source

Device Recall

External ID

Z-1566-2022

Action Date

2022-08-31

Status

Ongoing

Product Description

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

Lot/Code Info: (1) Centricity Universal Viewer 6.0 - UDI 00840682103800; Software versions 6.0 SP9, 6.0 SP9.0.1 through 6.0 SP9.0.1.11, 6.0 SP9.0.2, and 6.0 SP10 through 6.0 SP10.4. (2) Centricity Universal Viewer 7.0 - UDI 00840682145794, 00840682145558; Software versions 7.0 through 7.0 SP0.0.4.9, 7.0 SP0.0.5, 7.0 SP0.1.0, and 7.0 SP1. (3) Universal Viewer 8.0 - UDI 00195278379610; Software versions 8.0, 8.0 SP0.1.0, and 8.0 SP0.1.1.

Quantity Affected: 1,690 devices

Reason for Recall

Inaccurate Distance and Area measurements with use of Global Stack viewport.

Distribution

Distribution was made to AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, WA, WI, and WV. There was government distribution and no military distribution. Foreign distribution was made to Argentina, Aruba, Australia, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, South Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, Panama, Peru, Poland, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-07-15

Company

GE Healthcare, LLC

Waukesha, WI

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 194 device recalls issued in the same week, part of 413 device-related FDA actions this month.

GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Healthcare, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does GE Healthcare, LLC have FDA actions?

GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1566-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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