It’s the latest problem for Philips Healthcare’s beleaguered CT scanner business, which last year was forced to shut down production at an Ohio plant after the FDA cited it for inadequate manufacturing controls.
The recall stems from Philips’ discovery of a software defect that led to the sign indication of the longitudinal position of some types of scans to be inverted, according to the FDA. Philips began addressing the problem with a Feb. 5 letter to customers identifying the problem the actions they need to take to fix it.
Philips recommends not using multi-planar reconstruction-derived images to identify the absolute position of the intervention for feet-first patient orientation, according to the federal safety watchdog. Engineers from the company are scheduling corrective software installations with customers, the FDA said.
The agency said the recall affects the following CT scanner models:
- Brilliance CT 64-channel w/Essence technology
- Brilliance iCT
- Brilliance iCT SP
- Ingenuity Core
- Ingenuity Core128
- Ingenuity CT
Each model also has dozens of different affected serial numbers – 424 units – the FDA said, from across the U.S. and around the world, in places as far away as Germany, Hong Kong, India, Iran, Malaysia, Myanmar, the United Arab Emirates, Tanzania, Uzbekistan and Vietnam.
Early in 2014, Philips was forced to shut down the Ohio plant that made the Brilliance iCT device due to FDA citations about inadequate manufacturing controls. Parent and Dutch conglomerate Royal Philips said in January that it had resumed shipments of the device from Cleveland. But 4th-quarter production ramp-up was sluggish, leading to a $265 million hit on the company’s 2014 results.