| Developers: | Philips |
| Date of the premiere of the system: | January 2020 |
| Branches: | Pharmaceuticals, medicine, healthcare |
2020: Warning about marriage in X-ray complexes, due to which contrast enters the brain
In early January 2020, Philips issued an urgent notice to warn its customers about marriage in X-ray complexes CombiDiagnost R90 GCF. This error is dangerous, since its occurrence at a certain position of the apparatus can cause a contrast substance to enter the patient's brain and cause a headache.
Violations were observed using the table tilt function. It turned out that pressing the "Table Up/Down" button can cause error 80, which locks the device in the specified state. In this case, due to a failure in the software, the system reboot is not able to restore the normal operation of the device, that is, the intervention of a maintenance specialist is required. According to Philips, although error 80 could potentially occur, it was not actually recorded.
When the device is locked in a certain position, there is a risk of a contrast agent entering the brain. This undesirable effect leads to the development of a severe headache, which persists until the patient is moved to a normal position.
Another problem of the X-ray complex CombiDiagnost R90 GCF is related to the system power distribution unit. This unit is the main power source for the systems, except for the X-ray generator, and includes a thermal switch to turn off power in case of overheating. Due to production violations, these thermal switches could be installed incorrectly, which means they are not able to disconnect the system in an emergency, increasing the fire hazard of the device.
Philips noted that the notification concerns all released R90 GCF CombiDiagnost systems. Users are strongly advised not to tilt the table using the "Table Up/Down" buttons, but instead to use the "Table Tilt Left/Right" buttons. In addition, due to the fire hazard of the device, it is recommended to carefully monitor the appearance of smoke in the office where the system is installed.
According to the company, there were no victims by January 13, 2020. Philips claims that it will soon fix all software and hardware errors.[1]
Notes
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