MASSDEVICE ON CALL — Philips Healthcare (NYSE:PHG) subsidiary Respironics got the FDA’s highest-level warning over a recall of certain Trilogy ventilators.
The devices were recalled over concerns that they may fail to provide breathing support. Respironics attributed the error to a faulty component on the device’s power management board, discovered during production testing.
The company initiated the recall last month, saying that the glitch may exist in Trilogy models 100, 200, and 202. The measure affects some 600 devices shipped in the U.S., France, United Kingdom, Hong Kong, India, Italy, Korea, Kuwait, the Netherlands and Singapore between Dec. 31, 2013, and Jan. 30, 2014.
The new warnings are the 2nd such Respironics recall in the past year. In June 2013, the FDA issued another Class I label on a recall of more than 19,000 V60 ventilators, also over a problem with power management systems.
The FDA applies its Class I label to recalls considered to be the most dangerous, those that may pose a risk of injury or death to patients.
MID’s latest device pairs with Intuitive Surgical’s da Vinci robot
Ohio medical device maker Minimally Invasive Devices launched commercial efforts for its Robotic FloShield laparoscopic vision system, which is designed specifically for compatibility with Intuitive Surgical’s (NSDQ:ISRG) da Vinci surgical robot.
Read more
Insulet welcomes kid insulin pump entrepreneur
Massachusetts diabetes devices maker Insulet (NSDQ:PODD) welcomed 11-year-old Katrina Diel on a tour of its headquarters and granted her "ambassador" status in honor of her entrepreneurial efforts making and selling decorative covers for Insulet’s OmniPod insulin pumps.
Read more
New tools in the battle for medtech digital security
Amid ever-growing momentum among healthcare stakeholders interested in medical device cybersecurity, hospitals and other members of the health system are collecting resources and tools to address networked medical devices.
Read more
Docs and device makers negotiate discrepancies in Sunshine disclosures
Compliance with the Physician Payments Sunshine Act isn’t as cut and dry as it seems, and "payments" that medtech makers may consider inconsequential may appear in doctors’ reports, creating discrepancies in each side’s depiction of the relationship.
Read more