It’s been several years since Philips declared their Forte nuclear camera end of life (EOL). Still, through the service and spare parts support of third party providers, many users have continued scanning patients with them. Now, however, this years-long arrangement may no longer be a viable one.
On September 19, Philips Sr. Manager of Post Market Surveillance issued an urgent field safety notice to all users of the Forte family to discontinue use until further notice. This applies to all Fortes, including the Powerpack, the Jetstream, or systems refurbished by Philips.
In the notice, Philips said “There is a possibility that a detector may fall unimpeded vertically to the end stops of its travel limit, due to mechanical failure, possibly making contact with a patient that could result in entrapment, serious injury, or death.” Essentially, anyone who keeps using the Forte runs the risk of hurting a patient, or worse, with a falling detector.
This news raises serious questions for facilities that have relied on the Philips Forte for their nuclear medicine studies. What's being done? How long will it take? What are our alternatives? Below, we'll address those questions with the information that's available now. Check back periodically to to see updates as they become available from Philips and the FDA.
What is Philips doing about it?
Philips is currently working to offer a field repair that will solve the problem. At this early stage, what will be done and how it will work remain to be seen. Whatever solution they propose will need to meet with the approval of the FDA before being implemented in field use during patient procedures.
How long do I have to stop using the camera?
There are, unfortunately, no definite answers on this. We’ve talked with engineers, employees at Philips, and concerned Forte users who have reached out to Philips for details. No one is saying for certain, but everyone is using the word "months" in their projections.
What are other cameras we can look at?
Between the Forte's EOL designation and this new safety notice, some users may be wondering if it isn't time to think about retiring their Forte camera for something that's, perhaps, a little newer, still supported by the manufacturer, and, of course, cleared for use. If this consideration is on your mind, there are some alternative models we can suggest.
If you're hoping for an equivalent camera, the GE Millennium MG and Siemens e.cam are similar in both age and technology. If you'd like an upgrade from the Forte, the Philips Brightview, GE Infinia, and Siemens Symbia E or S are all part of the generation of cameras that came after the Forte. These systems are both generally newer and have improvements in technology. Another option would be to move to SPECT/CT with systems like the GE Infinia Hawkeye, or Siemens Symbia T series.
If you hope to keep your Forte, there's nothing to do right now but wait. If you're open to considering a different camera or SPECT/CT, there are secondary market options that can help you make the move affordably. At this early stage, there's little more we can share. We will, however, continue to follow the situation as it unfolds and provide updates to this blog as they become available. Be sure to check back with us soon for more from Philips and the FDA.