Recall Z-1584-2023 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
| Date | May 12, 2023 (initiated Mar 17, 2023) |
| Status | Open, Classified |
| Reason | Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Correction notification letter dated 3/17/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users Immediately stop using the Unload Pedal of the Foot Switch until Philips installs a solution on your system. Instead of using the Unload Pedal, please use the Unload Patient function on the Gantry Control Panels, or use other Table In/Out, Up/Down functions on the Gantry Control Panels, CT Scan Control Box, or Hardware Interventional Controls to fulfill the normal patient unloading function, as instruc |
| Quantity | 92 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of States: AZ, IN, MA, MD, MN, NY, OH, PA, and TX. The countries of Australia, Austria, China, Czech Republic, Denmark, France, Germany, Israel, Japan, Malaysia, Netherlands, Norway, Palestine, Panama, South Korea, Spain, Switzerland, Th |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203020 | Spectral CT Philips Medical Systems Nederland B.V., Feb 26, 2021 |