The FDA is providing a summary of this company's correction or removal action. Use of these products may cause serious injuries or death.
- Product Name: Philips Medical System (Cleveland) Forte Gamma Camera System
- Model/Lot Number: See Complete List of Recalled Products
- Unique Device Identification Number: (placeholder)
- Reason for Recall: Potential for the Detector to Drop
- Number of Products Affected in the U.S.: 500
- What to Do: Follow Company's Specific Actions
- Manufacturing Dates: January 1, 1998 to December 31, 2008
- Distribution Dates: January 1, 1998 to December 31, 2008
- Date Recall Initiated by Firm: September 19, 2019
- FDA Recall Classification Date: November 4, 2019
Recall Status: Open
The Philips Medical System Forte Gamma Camera System is used by health care providers to view images of structures or functions inside the body of patients to diagnose, plan treatment for, and evaluate many conditions. Before the test, a patient receives a contrast agent that is used as part of the imaging exam.
Reason for Recall
Philips Medical System is recalling the Forte Gamma Camera System due to the potential for an internal component to fail which can cause the gamma camera detector (660 pounds) to drop in an uncontrolled manner to the end of its range of motion, without a command from the clinician. If the detector drops to the end of its range of motion, it could result in a serious injury, such as crushing or trapping the patient, or death.
Philips Medical System received one customer complaint. No serious injuries or deaths were reported.
Who May Be Affected
- Patients undergoing imaging procedures using the Forte Gamma Camera System
- Health care providers using the Forte Gamma Camera System
On September 19, 2019 Philips Medical System sent a letter to customers who purchased the affected systems and provided instructions. Health care facilities, distributors, and other customers must:
- 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 email it to CTNM.QARA@Philips.com
Customers who have questions or need additional information or support regarding this recall should contact their local Philips representative in the Customer Care Solutions Center at 1-800-722-9377.
How to Report a Problem
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
- 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)
The FDA has identified this as a Class I recall, the most serious type of recall.