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FDA Recalls GE’s Infinia Hawkeye 4 Nuclear Medicine System used in Nuclear Medicine Imaging for Detection of Radioisotope Tracer Uptake in the Patient’s body

Reporter: Aviva Lev-Ari, PhD, RN

Hospital Death Forces Recall of GE Healthcare‘s Nuclear Medicine Machines

7/30/2013 7:36:26 AM

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Hospital patients face delays after 120 nuclear medicine machines were recalled across Australia following the death of a patient in the US. Authorities ordered hospitals across Australia to stop using the nuclear medicine imaging systems, preventing patients from being scanned while the machines are checked for safety. A 66-year-old patient being scanned in a veterans’ hospital in New York was crushed when a GE Healthcare Infinita Hawkeye 4 system collapsed when bolts securing the machine came loose.

http://www.devicespace.com/news_story.aspx?NewsEntityId=304157&type=email&source=DS_073013

 

Hospital death forces recall of nuclear medicine machines across Australia

HOSPITAL patients face delays after 120 nuclear medicine machines were recalled across Australia following the death of a patient in the US.

Authorities ordered hospitals across Australia to stop using the nuclear medicine imaging systems, preventing patients from being scanned while the machines are checked for safety.

A 66-year-old patient being scanned in a veterans’ hospital in New York was crushed when a GE Healthcare Infinita Hawkeye 4 system collapsed when bolts securing the machine came loose.

The recall notice was sent to Australian hospitals including the Women’s and Children’s Hospital more than a month later on July 9.

Six of 91 systems in Australian centres checked so far require repair to prevent a similar collapse, according to federal health officials, with 29 still to be checked.

Ten were operating in South Australian hospitals including two at the Royal Adelaide Hospital and one each at the Women’s and Children’s, the Queen Elizabeth Hospital and Lyell McEwin Hospital, with the others in private clinics.

GE Healthcare inspectors have inspected seven of these so far and not found any problems,.

SA Health, however, so far has only released one at the RAH and one at the QEH for use.

It released a statement to The Advertiser saying it had “a fleet of gamma cameras across South Australian public hospitals.”

“Five were identified as being in scope of the review,” the statement says. “Use of these five cameras was suspended immediately and GE is currently in the process of reviewing the machines. Two cameras have already been cleared and have resumed scanning.

“SA Health is working with GE Healthcare to minimise the impact on patients during this review.

“However some patient appointments have required rescheduling or rebooking on a different camera. There have been no incidents involving SA Health cameras.”

The systems, estimated to be worth from $300,000 to $800,000 depending on the model, track radiation emitted by radioactive fluids injected into patients to build images of organs and deep tissue to diagnose a range of diseases.

Information generated can pinpoint diseases before anatomical changes in organs and has some advantages over some other scanning techniques such as MRI and CAT scans.

Patients lie on their back with lead encased panels housing gamma cameras above and around them to track the radiation, and the entire machine can weigh in excess of 2000kg.

No deaths or injuries related to the safety issue have been reported in Australia.

The Therapeutic Goods Administration released a statement over the recall, advising patients to speak to their health professional if they have concerns.

“Due to the prevalence of affected nuclear medicine imaging systems in Australia and the need to have such systems inspected regarding this issue before use, there may be delays in accessing some diagnostic scan services,” the statement says.

In its letter to hospital officials GE Healthcare chief medical office Dr Douglas Hansell says: “Please be assured that maintaining a high level of safety and quality is our highest priority.’

http://www.news.com.au/national-news/south-australia/hospital-death-forces-recall-of-nuclear-medicine-machines-across-australia/story-fnii5yv4-1226680886436

 

GE Healthcare Nuclear Medicine Systems

Recall Class:  Class I

Date Recall Initiated: June 13, 2013

Products: Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine Systems, Helix Nuclear Medicine Systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670

Models: Infinia 3/8, Infinia-II 3/8, Infinia VC, Infinia II VC, Infinia 3/8 Hawkeye, Infinia VC Hawkeye, Infinia II 3/8 Hawkeye, Infinia II VC Hawkeye, Infinia II 3/8 HE4, Infinia II 5/8 HE4, Infinia II VC HE4, Varicam, Millennium VG 3/8, Millennium VG 5/8, Millennium VG 3/8 Hawkeye, Millennium VG 5/8 Hawkeye, Discovery VH, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670

These affected products were distributed from October, 1992 through June, 2013.

Use:  These Nuclear Medicine systems are used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient’s 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. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET – also known as Coincidence Detection). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

Recalling Firm: 
GE Healthcare, LLC
3000 N Grandview Blvd.
Waukesha WI 53188-1615

Manufacturer:  
GE Medical System Israel Ltd
4 Hayozma St.
Tirat Hacarmel, Israel

Reason for Recall: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals that they were recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In the second notification, GE included all Nuclear Medicine Systems.

Public Contact: For questions about this recall contact GE Healthcare Service Representative at 1-800-437-1171

FDA District: Minneapolis District Office

FDA Comments:

On June 17, 2013 GE sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures were executed according to labeling. In addition, the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment.

On July 03, 2013 GE notified customers again via an Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone calls. Healthcare facilities are instructed to cease use of their Nuclear Medicine system until a GE Healthcare Field Engineer is able to do a complete inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.

Physicians: No action is required beyond the recommendations provided in the Urgent Medical Device Recall letter.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm362946.htm

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