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U.S. Department of Health and Human Services

Class 2 Device Recall Discovery NM 530c

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  Class 2 Device Recall Discovery NM 530c see related information
Date Initiated by Firm November 30, 2018
Date Posted June 03, 2020
Recall Status1 Open3, Classified
Recall Number Z-2259-2020
Recall Event ID 85746
510(K)Number K080124  
Product Classification System, tomography, computed, emission - Product Code KPS
Product System, Tomography Computed Emmission
Code Information Model for Discovery NM 530c: 5248934, 5166674-01, H3000SA, H3001JA, H3001JD.  Serial Numbers:  19016,0000000ME11041,19069,19098,19082,19070,19086,19027,19044,19083,19065,19062,19048,19009,19109,19015,19040,19085,19012, 19108, 19030, 19057,000000109961-1,19002,16001,16007,19008,19097,19072,19080,16020,19026,19005,19025,0000000000ME-4. 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.
FDA Determined
Cause 2		 Other
Action GE Healthcare identified that a small number of Nuclear Medicine systems are operating without currently updated software.
Quantity in Commerce 526 total units
Distribution Domestic Distribution: AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, IA, IL, IN, KY, LA,MA, MD, ME, MI, MN, MO, MS, NC, NE, NM, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT,VA, WI and WV. Foreign Distribution: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Ghana, India, Israel, Italy, Japan, Korea, Malaisya, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Sweden, Taiwan, Thailand, Turkey and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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