OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy,
Summary
The FDA issued a Class II for OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and dig by GE OEC Medical Systems, Inc. Reason: There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable..
Details
Source
Device Recall
External ID
Z-2161-2021
Action Date
2021-08-04
Status
Terminated
Category
device
Product Description
OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Lot/Code Info: All OEC Elite systems manufactured on or after January 2019
Quantity Affected: 3570 units
Reason for Recall
There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
Distribution
Worldwide distribution - US Nationwide distribution including in the states of CA, PA, WA, OH, LA, MS, AL, FL, MO, OK, AZ, NJ, CO, MI, NV, MN, KS, TN, NC, IL, MD, SC,GA, UT, WI, MT, AR, WV, ID,CT, IA, WY, VT, KY, DC, SD,ME, Virgin Islands and the countries of Colombia, Egypt, Peru, Chile, Spain, France, Germany, Hong Kong, Canada, Japan, Brazil, Turkey, United Arab Emirates, Singapore, Australia, Thailand, United Kingdom, Italy, Korea, Russia, CHINA, Romania, Nigeria, Czechia, Argentina, Taiwan, Bangladeh, Malaysia, Bosnia and Herzegovina, Poland, Belgium, Indonesia, Dominican Republic, Switzerland, Hungary, New Zealand, Vietnam, Mexico, India, Norway, Philippines, Ecuador, Lithuania, HONDURAS, Uruguay, Sweden, Croatia, Jamaica, Kuwait, Ethiopia, Saudi Arabia, Finland, Bahamas, Trinidad and Tobago, Pakistan, Slovakia, Costa Rica, Israel, Panama, Greece, South Africa and DENMARK.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-10
Company
Salt Lake City, UT
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 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE OEC Medical Systems, Inc has 12 FDA actions in our database, including 11 recalls and 1 clearance.
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 OEC Medical Systems, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE OEC Medical Systems, Inc have FDA actions?
GE OEC Medical Systems, Inc has 12 FDA actions in our database, including 11 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2161-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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