Feature | Molecular Imaging | November 05, 2019| Dave Fornell, Editor

Philips Forte SPECT Camera Recalled for Possibility of Crushing Patient

Older gamma camera is under a Class I recall

Philips Medical System is recalling its older Forte Gamma Camera SPECT imaging systems due to the possibility of the detectors falling off of the unit onto the patient. The two gamma cameras can bee seen in this photo on either side of the patient bed. These can be rotated above the patient.

Philips Medical System is recalling its older Forte Gamma Camera SPECT imaging systems due to the possibility of the detectors falling off of the unit onto the patient. The two gamma cameras can bee seen in this photo on either side of the patient bed. These can be rotated above the patient.

November 5, 2019 — Philips Medical System is recalling the Forte Gamma Camera System due to the potential for the 660-pound detector to detach from the device without warning. The vendor said this could result in a serious injury, such as crushing, trapping or killing the patient. The U.S. Food and Drug Administration (FDA) reported Philips received one customer complaint, but no serious injuries or deaths were reported.

The FDA said this is a Class I recall, due to potential for the nuclear imaging detector to become detached, which can result in injury or death. Philips told its customers to discontinue use of the Forte Gamma Camera System until further notice. Philips initiated its recall Sept. 19, 2019. It includes 852 devices recalled in the United States.

The FDA and Philips are taking precautions because of a June 2013 accident, when the detector on a GE Healthcare SPECT system fell onto a patient and killed them during a scan at the James J. Peters VA Medical Center in the Bronx, N.Y. That incident resulted in a similar recall at the time for GE's nuclear imaging systems. Read the article Patient Killed During Nuclear Imaging Scan.

The Forte Gamma Camera System is an older single photon emission computed tomography (SPECT) nuclear imaging system. These systems were manufactured between Jan. 1, 1998 and Dec. 31, 2008. It is used to create images of structures or functions inside the body of patients using a radioisotope tracer to diagnose, plan treatment and evaluate many conditions, including cancer and cardiac perfusion.

The recalled products include the following imaging system:
   • Philips Medical System Forte Gamma Camera System
   • Forte (882020)
   • Forte Jetstream (882290)
   • Forte Jetstream upgrade (882291)
   • Forte Jetstream AZ (882320)
   • Forte Jetstream AZ upgrade (882321)
   • Diamond Select Forte (889456)
   • Diamond Select Forte JETStream (889471)

A portion of the gamma camera head weight comes from the heavy lead collimators built into them. 

Philips sent a letter to customers who purchased the affected systems and provided the following instructions:
   • Discontinue use of the Forte Gamma Camera System until further notice
   • Maintain the letter with the Forte Gamma Camera System until a correction is made to the system
   • Complete the Customer Response Form and e-mail it to [email protected]

Healthcare providers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Access original FDA recall notice

Related Content

The Mindways Solid phantom with volume of interest in the quality assurance phantom (red circles, left side). A participant's noncontrast-enhanced axial CT (right side) with volume of interest (yellow circles) in the trabecular bone compartment of three vertebrae for bone mineral density measurements. Image courtesy of Radiological Society of North America

The Mindways Solid phantom with volume of interest in the quality assurance phantom (red circles, left side). A participant's noncontrast-enhanced axial CT (right side) with volume of interest (yellow circles) in the trabecular bone compartment of three vertebrae for bone mineral density measurements. Image courtesy of Radiological Society of North America

News | Cardiac Imaging | July 15, 2020
July 15, 2020 — ...
Cardiac MR can offer data above and beyond anatomical imaging, which is the main reason why this system was installed at Baylor Scott White Heart Hospital in Dallas. The system is a dedicated heart MRI scanner.

Cardiac MR can offer data above and beyond anatomical imaging, which is the main reason why this system was installed at Baylor Scott White Heart Hospital in Dallas. The system is a dedicated heart MRI scanner.

News | Cardiac Imaging | June 29, 2020
June 29, 2020 — A type of smart magnetic r...
New Multimodality Cardiac Imaging Guidelines for Competitive Athletes Created. ASE SCCT and SCMR recommendations for imaging, screening atheletes.
News | Cardiac Imaging | May 11, 2020
May 11, 2020 – Competitive athletes are a rapidly growing population worldwide.
Figure 4 for the study. Images of a 65-year-old man (patient 6). (a) Cardiac MRI perfusion shows perfusion deficit of anterior/anterolateral wall attributed to left anterior descending artery/left circumflex artery (*). (b) CT coronary angiography. (c) Coronary angiography, left anterior oblique projection with caudal angulation. (d) Three-dimensional image fusion helped refine diagnosis: perfusion deficits (*) were most likely caused by narrow first diagonal branch and its first, stented side branch (arrow

Figure 4 for the study. Images of a 65-year-old man (patient 6). (a) Cardiac MRI perfusion shows perfusion deficit of anterior/anterolateral wall attributed to left anterior descending artery/left circumflex artery (*). (b) CT coronary angiography. (c) Coronary angiography, left anterior oblique projection with caudal angulation. (d) Three-dimensional image fusion helped refine diagnosis: perfusion deficits (*) were most likely caused by narrow first diagonal branch and its first, stented side branch (arrowhead). Retrospectively, denoted lesion could also be found at CT coronary angiography and coronary angiography (arrowheads in b and c, respectively). CT FFR = CT-derived fractional flow reserve, LGE = late gadolinium enhancement. Image courtesy of RSNA, Radiology.

News | Cardiac Imaging | May 04, 2020
May 4, 2020 – A new technique that combines computed tomography (CT) and magnetic resonance imaging MRI can bolster c
An example of a coronary computed tomography angiography (CCTA) exam. The CIAO study looked at patients who have a problem of blood flow limitation and chest pain symptoms in the absence of a 50 percent or more artery narrowing, known as ischemia with no obstructive CAD, or INOCA.

An example of a coronary computed tomography angiography (CCTA) exam. The CIAO study looked at patients who have a problem of blood flow limitation and chest pain symptoms in the absence of a 50 percent or more artery narrowing, known as ischemia with no obstructive CAD, or INOCA.

News | Cardiac Imaging | April 03, 2020
April 3, 2020 — Patients who experience chest pain and have abnormal results on a cardiac stress test but who do not
Schematic depiction of the automated process for assessing fat, muscle, liver, aortic calcification, and bone from original abdominal CT scan data

Figure 1: Depiction of the fully automated CT biomarkers tools used in this study. (A) Schematic depiction of the automated process for assessing fat, muscle, liver, aortic calcification, and bone from original abdominal CT scan data. (B) Case example in an asymptomatic 52-year-old man undergoing CT for colorectal cancer screening. At the time of CT screening, he had a body-mass index of 27·3 and Framingham risk score of 5% (low risk). However, several CT-based metabolic markers were indicative of underlying disease. Multivariate Cox model prediction based on these three CT-based results put the risk of cardiovascular event at 19% within 2 years, at 40% within 5 years, and at 67% within 10 years, and the risk of death at 4% within 2 years, 11% within 5 years, and 27% within 10 years. At longitudinal clinical follow-up, the patient suffered an acute myocardial infarction 3 years after this initial CT and died 12 years after CT at the age of 64 years. (C) Contrast-enhanced CT performed 7 months before death for minor trauma was interpreted as negative but does show significant progression of vascular calcification, visceral fat, and hepatic steatosis. HU=Hounsfield units.

News | Cardiac Imaging | March 06, 2020
March 6, 2020 — Researchers at the National Institutes of Health a
ASNC Announces Multisocietal Cardiac Amyloidosis Imaging Consensus
News | Cardiac Imaging | September 09, 2019
The American Society of Nuclear Cardiology (ASNC) published a new expert consensus document along with eight other...