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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus XR/a Radiographic System

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 Class 2 Recall
Proteus XR/a Radiographic System
see related information
Date Posted September 25, 2007
Recall Status1 Terminated on December 11, 2007
Recall Number Z-1087-2007
Recall Event ID 38633
Premarket Notification
510(K) Number
K993090 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.
Code Information 30920HL3, 30921HL1, 31931HL9, 3457OHL2, 34864HL9, 34911HL8, 35136HL1, 35191HL6, 35244HL3, 35936HL4, 36207HL9, 36361HL4, 36431HL5, 36521HL3, 36702HL9, 36704HL5, 37009HL8, 37261HL5, 37395HL1, 37396HL9, 37597HL2 & 993702WK0
Recalling Firm/
Manufacturer
General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Consignees were notified of the problem by a visit. To address the Proteus System shipped to the field, a Field Modification (FMI) was created to correct units in the field.
Quantity in Commerce 22 units
Distribution Nationwide; including states of WA,KS, CO, NM, NC, FL, MT, AZ, TX, IL, NY, MD, and GA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = GE MEDICAL SYSTEMS, INC.
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