• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall GE Precision 500D

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall GE Precision 500D see related information
Date Posted September 19, 2008
Recall Status1 Terminated on December 10, 2011
Recall Number Z-1610-2008
Recall Event ID 49467
510(K)Number K011624 
Product Classification Fluoroscopic X-Ray System - Product Code JAA
Product GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276, 2407576, 5179385, 2289299-2, 2290479-2, 2345260-12, 2345260-3, 2403790-3, and 2403791-3, GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.
Code Information 00001009774WK9, 00001009775WK6, 00001009857WK2, 00001009858WK0, 00001009859WK8, 00001009860WK6, 00001009889WK5, 00001009939WK8, 00001009940WK6, 00001009941WK4, 00001009943WK0, 00001001973WK5, 00001002235WK8, 00001005072WK2, 00001008710WK4, 00001008860WK7, 00001008918WK3, 00000007106M38, 00000001537M30, 00001004816WK3, 00000098420DP3, 00000000BRENFR, 00000000BRERRL, 00000000BRF4AZ, 00000000BJ0EF3, 00000000BRDDLG, 00000030784B13, 00000060784HP6, 00000061499HP0, 00000067009DP1, 00001009986WK9, 00001010013WK9, 00001010014WK7, 00001010015WK4, 00001010016WK2, 00001010017WK0, 00001010018WK8, 00001010019WK6, 00001010020WK4, 00001010021WK2, 00001010059WK2, 00001010060WK0, 00001010061WK8, 00001010063WK4, 00001010064WK2, 00001010065WK9, 00001010066WK7, 00001010068WK3, 00001010091WK5, 00001010120WK2, 00001010208WK5, 00001010209WK3, 00001010210WK1, 00001010211WK9, 00001010212WK7, 00001010213WK5, 00001010214WK3, 00001010215WK0, 00001010216WK8, 00001010217WK6, 00001010287WK9, 00001010328WK1, 00001010329WK9, 00001010330WK7, 00001010331WK5, 00001010333WK1, 00001010334WK9, 00001010335WK6, 00001010336WK4, 00001010337WK2, 00001010550WK0, 00001010551WK8, 00001010552WK6, 00001010553WK4, 00001010554WK2, 00001010555WK9, 00001010556WK7, 00001010739WK9, 00001010741WK5, 00001010743WK1, 00001010744WK9, 00001010745WK6, 00001010746WK4, 00001010747WK2, 00001010748WK0, 00001010854WK6, 00001010855WK3, 00001010856WK1, 00001010859WK5, 00001010860WK3, 00001010861WK1, 00001010862WK9, 00001010863WK7, 00001011010WK4, 00001011011WK2, 00001011012WK0, 00001011013WK8, 00001011029WK4, 00001011030WK2, 00001011031WK0, 00001011033WK6, 00001011035WK1, 00001011036WK9, 00001011037WK7, 00001011200WK1, 00001011201WK9, 00001011202WK7, 00001011203WK5, 00001011204WK3, 00001011205WK0, 00001011206WK8, 00001011207WK6, 00001011208WK4, 00001011209WK2, 00001011320WK7, 00001011321WK5, 00001011327WK2, 00001011328WK0, 00001011340WK5, 00001011341WK3, 00001011342WK1, 00001011343WK9, 00001011344WK7, 00001011345WK4, 00001011346WK2, 00001011347WK0, 00001011348WK8, 00001011349WK6, 00001011513WK7, 00001011514WK5, 00001011515WK2, 00001011516WK0, 00001011517WK8, 00001011518WK6, 00001011519WK4, 00001011520WK2, 00001011521WK0, 00001011657WK2, 00001011761WK2, 00001011762WK0, 00001011763WK8, 00001011764WK6, 00001011765WK3, 00001011766WK1, 00001011767WK9, 00001011768WK7, 00001011769WK5, 00001011770WK3, 00001011875WK0, 00001011876WK8, 00001011877WK6, 00001011878WK4, 00001011879WK2, 00001011887WK5, 00001011888WK3, 00001011889WK1, 00001011890WK9, 00001011891WK7, 00001012024WK4, 00001012025WK1, 00001012026WK9, 00001012027WK7, 00001012028WK5, 00001012029WK3, 00001012030WK1, 00001012031WK9, 00001012032WK7, 00001012033WK5, 00001012176WK2, 00001012177WK0, 00001012178WK8, 00001012179WK6, 00001012180WK4, 00001012181WK2, 00001012182WK0, 00001012183WK8, 00001012186WK1, 00001012187WK9, 00001012188WK7, 00001012189WK5, 00001012190WK3, 00001012191WK1, 00001012192WK9, 00001012193WK7, 00001012194WK5, 00001012195WK2, 00001012432WK9, 00001012434WK5, 00001012435WK2, 00001012499WK8, 00001012500WK3, 00001012501WK1, 00001012502WK9, 00001012503WK7, 00001012505WK2, 00001012506WK0, 00001012508WK6, 00001012541WK7, 00001012542WK5, 00001012543WK3, 00001012546WK6, 00001012547WK4, 00001012548WK2, 00001012549WK0, 00001012881WK7, 00001012883WK3, 00001012884WK1, 00001012885WK8, 00001012888WK2, 00001012889WK0, 00001012991WK4, 00001012992WK2, 00001012993WK0, 00001012994WK8, 00001012995WK5, 00001012996WK3, 00001012997WK1, 00001012998WK9, 00001013087WK0, 00001013088WK8, 00001013089WK6, 00001013090WK4, 00001013102WK7, 00001013176WK1, 00001013177WK9, 00001013178WK7, 00001013179WK5, 00001013181WK1, 00001013182WK9, 00001013183WK7, 00001013184WK5, 00001013185WK2, 00001013293WK4, 00001013294WK2, 00001013298WK3, 00001013299WK1, 00001013301WK5, 00001013302WK3, 00001013576WK2, 00001013577WK0, 00001013578WK8, 00001013579WK6, 00001013580WK4, 00001013581WK2, 00001013582WK0, 00001013583WK8, 00001013584WK6, 00001013585WK3, 00001013726WK3, 00001013728WK9,
Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-544-3894
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall
GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube when the Primary Protective Barrier was not in position to intercept the X-ray beam. Users are recommended to follow good clinical standards to ensure the Image I
FDA Determined
Cause 2
Nonconforming Material/Component
Action A Product Safety Notification letter, dated 01/09/2008 was sent to affected customers. This letter described the safety issue, affected product and safety instructions. A GE Field Engineer will schedule a field visit to affected customers to inspect and replace the park latch switch as needed.
Quantity in Commerce 2863 total (2744 US / 119 OUS)
Distribution Nationwide, Washington D.C. and Puerto Rico and OUS to include: ARGENTINA, AUSTRALIA, BRAZIL, CANADA, CHILE, DOMINICAN REPUBLIC, EGYPT, GERMANY, HONDURAS, INDIA, INDONESIA, IRELAND, JAMAICA, KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, PANAMA, RUSSIAN FEDERATION, SAUDIA ARABIA, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM,
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 = JAA and Original Applicant = GE MEDICAL SYSTEMS
-
-