Class 2 Device Recall GE Healthcare Infinia Hawkeye

• Date Initiated by Firm: September 08, 2008
• Date Posted: April 10, 2009
• Recall Status: Terminated on May 24, 2012
• Recall Number: Z-1094-2009
• Recall Event ID: 50990
• 510(K)Number: K022960
• Product Classification: Emission computed tomography system - Product Code KPS
• Product: GE Healthcare Infinia Hawkeye(R), Model numbers:; H2508PY ; H3000WN ; H3000WR ; H3000WW ; H3000WY ; H3000WZ ; H3000YM ; H3000YS ; ; Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
• Code Information: H2508PY : S/N 16076 16010 16177, and 16175. H3000WN: 16433 and 16366 H3000WR: 16275, 16306, and 16379. H3000WW: 16584 16690 16146 16328 16292 16530 16574 16619 16321 16545 16586 16193 16351 16393 16435 16439 16471 16217 16274 16459 16438 17022 16347 16302 16717 16689 16989 16998 17039 16480 16584 16593 16568 16458 16951 16711 16417 16906 17038 16458 16727 16003 16247 16386 16729 16402 16402 16398 16529 16708 16708 16277 16754 16294 16604 16591 16642 16383 16383 16463 16268 16554 16690 16467 16357 16316 16879 16367 16745 16535 16675 16581 16399 16501 16507 16222 16461 16602 16769 16782 16956 16836 16445 16445 16493 16384 16486 16693 16894 16343 16452 16801 16631 16633 16931 16631 16618 16200 16702 16818 16341 16556 16299 16345 16329 16753 16348 16257 16610 16258 16707 16369 16253 16958 16284 16703 16252 16638 16254 16278 16333 16231 16368 16709 16265 16488 16884 16330 16845 16558 16630 16490 16855 16563 16599 16431 16414 16714 16327 16360 16647 16577 16883 16625 16605 16605 16201 16892 16603 16652 16623 16339 16671 16270 16407 16476 16416 16390 16451 16424 16952 16276 16236 16496 16895 16484 16654 16620 16230 16406 16985 16359 16273 16597 16482 16429 16338 16338 16607 16388 16847 16573 16606 16824 16472 16981 16374 16835 16562 16288 16241 16609 16203 16508 16342 16363 16444 16260 16678 16342 16202 16598 16550 16615 16440 16362 16506 16272 16389 16936 16332 16508 16521 16687 16629 16588 16700 16358 16307 16432 16595 16997 16787 16590 16653 16580 16287 16514 16515 16555 16777 16192 16555 16199 16385 16764 16544 16232 16523 16256 16954 16954 16982 16309 16242 16242 16257 16644 16797 16267 16283 16280 16549 16596 16637 16691 16697 16757 16980 16681 16684 16679 16730 16546 16352 H3000WY: 16616 17083 16282 16897 16532 16143 16423 16204 17085 16423, and 16289. H3000WZ: 16350 16752 16375 16582 16237 16238 16183 16176 16403 16468 17148 16239 16349 16572 16996 16086 16240 16552 16485 16815 16813 16826 17079 16601 16495 16522 16240 16264 16248 16624 16961 16780 16409 16205 16387 16487 16481 16891 16449 16361 16215 16831 16462 16261 16512 16578 16197 16205 16565 16430 16397, and 16251. H3000YM: 16146 16057 16133 16100 16157 16172 16024 16174 16147 16125 16164 16120 16131 16127 16132 16040 16024 16128 16052 16055 16070 16013 16011 16029 16110 16028 16009 16060 16173 16008 16082 16027 16151 16153 16154 16064 16163 16007 16030 16037 16124 16046 16020 16112 16121 16103 16063 16169 16035 16042 16059 16109 16021 16159 16062 16073 16073 16148 16149 16156 16053 16053 16038 16019 16023 16078 16150, and 16101. H3000YS: 16061 16134 16095 16085 16152 16089 16074 16168 16141 16067 16068, and 16056.
• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head.
• FDA Determined Cause: Software design
• Action: Consignees were sent from September 2008 - Feb 2009 a GE "Product Safety Notification" letter dated 4/2008. The letter was addressed to Hospital Administrators, and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. It instructed consignees to continue to use the Infinia Hawkeye system normally for all types of Hybrid scans and stated that as a general practice tomograms should be reviewed carefully using the Xeleris Volumetrix processing protocol to ensure proper registration. Local sales or service reps should be contacted for further information regarding the notification.
• Quantity in Commerce: 153 US, 264 OUS
• Distribution: Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, DC, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK ,OR, PA, PR, SD, TN, TX, UT, VT, VA, WA, WV, and WI and countries of AUSTRALIA, BELGIUM , BRASIL, CANADA, CHINA, COLUMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GEORGIA, GERMANY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, NEW Zealand, NORWAY, POLAND, PUERTO RICO, RUSSIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA