Conglomerate Receives More Bad News From FDA

GE Healthcare has received its second warning letter in 2007, this time related to its diagnostic X-ray devices, just three weeks before it planned to notify the FDA that it was working to address manufacturing issues identified in a separate warning letter for its MRI coil and breast biopsy plate operations.

The most recent warning letter, issued Nov. 16, concerns two diagnostic X-ray devices that deviated from performance standards.

An FDA inspector conducted field tests at a hospital Sept. 27 on the X-ray control systems and found the products’ primary protective barriers were not in the correct position to intercept X-ray beams, according to the letter posted on the agency’s website in December.

The firm’s previous MRI warning letter was issued in April. The company expects a follow-up inspection for that unit during the first half of 2008.

The X-ray warning letter can be accessed at www.fda.gov/foi/warning_letters/s6584c.pdf.