Regulatory Focus™ > News Articles > Hospira Initiates Class I Recall for Touchscreen, Software Issues

Hospira Initiates Class I Recall for Touchscreen, Software Issues

Posted 30 October 2012 | By

Medical device manufacturer Hospira has issued a voluntary Class I recall in the US for its Symbiq Infusion system after being made aware that the device's LCD touch screens were occasionally unresponsive, causing errors, treatment delays, incorrect treatment or treatment interruptions.

The class of devices is used to deliver exact amounts of medication to patients, and Hospira markets it as a method to achieve compliance with good clinical practice guidelines.

In a statement, Hospira urged doctors to weigh the benefits and risks of continued use of the device, but said the device has a built-in confirmation screen meant to avoid errors associated with accidental or incorrect data entry. The device, it added, did not need to be returned if it was functioning properly, but affected devices should be removed from use.

The company had previously sent an urgent Medical Device Correction letter to physicians in August 2012 regarding the issue, but expanded its warnings to a voluntary recall on 29 October 2012.

One Recall, Multiple Causes

The root causes of the failure are manifold, wrote Hospira.

"Hospira has completed an investigation into customer reports and has found the major contributor to be software related. Other contributing root causes that have been identified include damaged connections, physical damage and other touch screen defects."

The company is arranging a software update for the devices which should fix the majority of the problems, which it said exist in approximately 1.5% of Symbiq devices.

Class I recalls are the most serious available, and are initiated if a company or FDA has a reasonable suspicion or cause to believe that the product could cause serious harm or be fatal to patients.

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