Philips ultrasound imaging systems recalled after 4 deaths
The U.S. Food and Drug Administration on Friday announced the recall of certain Philips ultrasound imaging systems following four deaths and eight serious injuries.
Authorities say the warning pertains to the Lumify line of diagnostic sonography systems. Due to a software issue, the Android or iOS app paired with its ultrasound transducers might not recognize a previously registered account.
This may prompt users to reregister without warning prior to point-of-care imaging, with scanning functionality halted until the step has been completed. In addition, there also is risk that the USB connection between the scanner and a phone or tablet may disconnect or become unstable.
“Because the Lumify system is intended for point-of-care use—where ultrasound imaging supports rapid diagnosis and treatment; real-time decision-making; triage of unstable patients; and access to diagnostic capabilities in mobile, underserved or remote settings—loss of functionality or system failure may have greater consequences than with traditional ultrasound devices,” the FDA said in its notice, dated Oct. 9. “Depending on the clinical situation and patient condition, delays in diagnosis or treatment could lead to serious injury or death.”
Philips first began notifying customers about the issue last month, with four reported fatalities occurring as of Sept. 29. The company said it is developing a software update—along with an appropriate solution for the USB issue—and will notify customers when it’s ready. Philips’ ultrasound business also has mobilized a dedicated taskforce to “urgently address this situation,” including customized advice and support to those who are impacted by the notice.
“Philips has intensified efforts to strengthen patient safety and quality across the company,” a representative told Radiology Business Friday. “We are methodically working through product quality at all levels and businesses in a multi-year program. We act on post-market surveillance signals, proactively issuing corrections, updates or recalls when we identify potential issues.”
To support customers who have deployed the Lumify system in low-resource settings, the Philips Foundation is partnering with local experts to “provide additional support and ensure continued access to care.”
Until the fix is issued, the FDA is urging providers to only use the system in areas with a readily accessible Wi-Fi or cellular signal, unless a backup ultrasound device is available. In its notice, Philips also urged customers to have an imaging Plan B in these situations, until the issue is fixed. The manufacturer additionally advised customers to circulate the letter to all users of the device and post a notice near the scanner for ease of reference.
Lumify devices deployed outside of the hospital—such as in ambulances, aircrafts or field settings—are at greater risk, due to limited Wi-Fi or cellular signals, according to the FDA. Philips has received reports that the unexpected reregistration events have prevented scanning in pre-hospital healthcare settings and delayed necessary treatments.
“Philips stated it is working to assess the cause of the connection issue and identify an appropriate solution,” the FDA added. “Updates will be communicated to customers as soon as further information is available.”
Affected devices include the Lumify Diagnostic Ultrasound System iOS 2.X, 5.0, 5.1.2, 5.1.3, along with Android versions 1.X, 3.X, 4.X, 5.1, and 5.1.1.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.