Following the death of a patient last month, GE Healthcare issued a recall for several of its nuclear imaging scanners. FDA regulators issued Class I recall status for all the affected models. (Note: For a breakdown of other recent Class I recalls, see Medical Device Recalls in June and July.)

In June, a patient undergoing a scan in an Infinia Hawkeye 4 was crushed to death by a falling camera. GE's recall states that the camera fell after the bolts securing it in place became loose.

For several weeks after the accident, GE warned healthcare providers to avoid the use of its Infinia scanners until they were inspected. Since there are design similarities between many of the company's nuclear medicine systems, GE has expanded its recall to include a larger number of models.

FDA regulators and GE have not stated how many devices are affected by the recall. GE also hasn't said how long the inspection process will take for affected devices. In a statement made on Monday, GE noted that it expanded its response to ensure "a high level of safety and quality."

"[The company] is dedicating resources to these activities so that the global installed base inspection activities can be completed appropriately and as quickly as possible," stated a spokesperson for the company.

Impacted systems include Millenium VG, Varicam and Infinia scanners. These systems are used in neurology, cardiology, oncology and other diagnostics.