Dive Brief:

• FDA has categorized the recall of Hillrom's overhead patient lift as a Class I event, citing the potential for serious harm, and said the device was linked to two deaths. In all, 34 complaints were lodged about the product, including 22 reports of serious injuries, FDA said Monday.
• The Liko Multirall 200 overhead lift is part of a motorized system that can be used to transport patients in a sitting position from room to room in hospitals and other healthcare facilities.
• The Chicago-based company sent a safety notice to affected customers in December warning that the lift could become detached from the ceiling rail system due to an unattached strap lock, causing the motor or patient to fall. 

Dive Insight:

The overhead lift system at the center of the recall is intended for hospitals, rehabilitation centers and nursing homes that have a need to lift and transfer patients. FDA said customer reports indicated the lift's Q-link strap lock did not attach properly to the S65 carriage hook.

In its safety notice to healthcare providers and distributors, Hillrom said it will be replacing the Q-link strap on the Multiralls lift with a Q-link 2 strap to improve ease of use and prevent risk to patients and caregivers. In the interim, providers are allowed to continue to use the system. They are also instructed to inspect the Multirall systems in their facilities and identify units affected by the field corrective action.

The company said there are 10,470 units in commerce. The devices were manufactured between December 2000 and October 2020 and distributed nationwide during the same period.

Known for its hospital beds, ventilators and other patient care equipment, Hillrom has more recently accelerated a push into the patient monitoring business with the acquisition, unveiled in January, of BardyDx, developer of a wearable biosensor-based platform, for $375 million in cash plus potential future milestone payments.

In February, Hillrom followed that deal with the announcement that it acquired a contact-free continuous monitoring technology from EarlySense for $30 million, potential milestone payments and a portion of its equity investment in the company. The technology will be integrated into the company's smart beds to help identify clinical deterioration in patients, with the aim of improving survival and decreasing intensive care unit admissions, Hillrom CEO John Groetelaars said on the company's first-quarter earnings call earlier this month.