FDAFDA · Food and drugs·Recall number Z-1078-2013
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
Published April 17, 2013 · Recall initiated: March 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide Distribution - USA (nationwide) including DC and PR and the countries of UKRAINE, TAIWAN, TURKEY, TUNISIA, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, PAKISTAN, PHILIPPINES, PANAMA, NEW ZEALAND, NORWAY NETHERLANDS, MALAYSIA, MEXICO, MALTA, MARTINIQUE, MOROCCO, LATVIA, LITHUANIA, LEBANON, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, IRAN, INDIA, ISRAEL, IRELAND, INDONESIA, HUNGARY, CORATIA, HONG KONG, GREECE, GEORGIA, UNITED KINGDOM, FRANCE, FINLAND, SPAIN, EGYPT, ECUADOR, ALGERIA, DOMINICAN REPUBLIC, DENMARK, GERMANY, CZECH REPUBLIC, CYPRUS, COLUMBIA, CHILE, SWITZERLAND, CANADA, CHINA, BRAZIL, BELGIUM, AUSTRALIA, AUSTRIA, ARGENTINA, SOUTH AFRICA, VENEZUELA, URUGUAY, ALGERIA.
- Lot
- System ID (As required) 787764INFINIA-1 SA2146NM01 TN1366NM01 SA1001MN01 PK1031NM01 PK1032NM01 PK1180NM08 PK1184NM01 PK1307NM01 PK1336NM01 MA1439NM01 LB1122NM02 KW1013NM01 KW1013NM02 KW1018MN06 KW1018MN08 EG1124MN02 323268INF1 630312INF 630545INF 630856INF 630275INF 330344INFINIA1 518262INF1 518262INF2 518262INF3 724226INF1 ARHINFI 610770INFINIA 502893INF 443481BINF 443481INF 443481INF2 661949NUC1 804594INF1 480323INFRM1 607737INF 404265INF 330363INFINIA 920451INF 920907INF 305682INF1 602588INF 904821INF3 904821NM1 904821NM2 615284INF1 904627INF2 904321INF1 904202INF1 501202INF 662244INFINIA 225381INF 972394INF 727863INF1 713359INF1 419483NUC2 406731INF1 228436INF 865977INF 804281INF1 804225INF1 941VRMCINF 248471INF 203384INF 269657SHINF 718240INF2 718240INF1 BCHINF1 513454INF1 843402INF2 843606INF1 609730INF1 GILESINF 217554CINF 843674IN1 843674IN2 843674IN3 704225INF1 704355INF1 704355INF2 704863INF1 770382INM 973877INFINIA 859313INF 423625INFINIA 859498INF1 937440INF2 606878INF1 606878INF2 512528NM1 305325INF 615342INF1 816380CASSINF 816392RINF 816836CIIN SLGHINF 207795INFINIA 518562INF 757312INF1 757312INF2 410337INF3 973831INFINIA 708684INF1 302733INF 318681INFINIA2 281599INF1 805489INF1 352344INF 256327NUC 704487INFINIA1 718948INF 843782INF 931403NM1 256429INF1 CFRHINF 727521INF 904276INF1 702255INF 210617NM1 847990INF1 814533INF2 814534INF 607756INF 607756INF2 740623INFINIA 319272INF CRAVENINF2 CRAVENINF3 CRAVENINF1 618544INF 402449INF 337436INF 318798INFINIA 203797INF 304637INF 205750INF 205759INF 256341NRM1 760778INF1 702369NM 760241INF1 850883ENM 904542NM 502624INF 727581INF 630786INF 786308INF1 786308INF2 214324INF 919684INF3 318330INF1 843412INF 504454INF 303837INF 330721INFINIA1 330721INFINIA2 502350INF 904819INF1 928214INF FHEINF 954735INF2 813788INF1 225647INF 318327INF1 318388INF1 601288INF1 865373INF 865429INFINIA 240566INF 256494NM1 316858GI 662256INFINIA 561650INF1 843692IN1 319768INF 319768INF2 770229INF 979532INF1 706278INF 828586INFINIA 262670INF2 978521INF 517543INF 727942INF 256386HKNM2 906293INF 618942INF 305835INF 847480INF 843689INF 605353NM 435251INF1 801357INF1 701364INF 703858INF 815432INFINIA 814643INF 773947INF 570398INF 502955INF 859268INF1 502259INF 732321INFINIA 954265INF1 561744INF 305227INF1 305227INF2 262656INF2 513867INF 441236INFINIA 704739INFI 281348INF 307332INFINIA 225658INF 772LMCNM2 901287INF1 LGMCINF 304831LNM1 951672INF1 805737INF1 805370INF1 304623INF1 304623INF2 609835INFINIA 707822INFINIA 409938INF 828696INFINIA1 252436INF1 415925INF 925779IN 740383INF1 843431IN 402461INF 931381NM2 843777IN1 843777IN2 814333INFINIA1 814333INFINIA2 478633INFINIA 732840INFINIA 580931INF1 727843INF1 815756INF 609267INF 713242INF2 713242INF3 432685DNUC 812522INF MVINFNM2 913345INF1 209385IN 419455INF1 701774NM 281274INF 402354INF 832522INF 832522INF2 614478INF1 615349NM1 615349NM2 860344INF 662772INFRM1 662772INFRM2 662772INFRM4 405610MINF1 617313INF1 603924INF 973971INFINIA 212241INF2 801465INF1 302629INF NASHNM2 601443INF1 518773INF 239NCHINF1 281897INF1 212608INF1 COR373273 COR373282 617243INFINIA 405307INF1 352333INF 225NOINF 985230INF 770219INF 770535INF1 210757NM1 215537INFINIA 985646INF 479751INF 954978INF1 203852INF 704316INFI 516IPKINF1 352596INF1 708660INF 734467INF 734671INF 228818INF 885INFI1 885INFI2 478454INF 801479INF 801479INF2 ORMCINFINIA2 OBNM1 913541INF1 908522INFINIA2 908522INFINIA3 417256INF 661PMCNUC1 845987INFINIA 435658INF 423493PINF 803329INFIN1 PITTINF5 571231INF1 571231INF2 610327INFINIA 303839INF 815432INF 248849INF1 248849INF2 903785INF 505863INF 816348INF1 804254INF 618395INF 601936INF1 732530INFINIA 256543INF1 325235NUC 843402INF 843724INF
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.