Royal Philips’ recall woes continued to captivate MPO website visitors this past week.

News the FDA deemed the company’s Dec. 7 recall of certain reworked ventilators (Philips Respironics Trilogy 100, Trilogy 200, and Garbin Plus ventilators) that were also recalled in June 2021 as Class I drove most site traffic.
 
BiPAP and CPAP machines reworked or replaced due to the June 2021 recall are not affected by this new notice. Adhesive is not used to hold the silicone foam in place in the reworked or replaced BiPAP and CPAP machines. The silicone sound abatement foam installed to replace PE-PUR foam may separate from the plastic backing due to adhesive failure. The silicone foam material may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. If an alarm is not recognized or acted upon, the patient could experience trouble breathing, such as asphyxia, hypoventilation, or hypoxemia, which can be life threatening. As of Jan. 4, there have been 82 MDRs (63 MDRs for foam delamination and 19 MDRs for particulate debris contamination) and no deaths.

Other news garnering significant page views over the last seven days included new product announcements from Asensus Surgical and Teleflex, details of KMM Group’s new Pennsylvania facility, and Dentsply Sirona’s restructuring effort.

Cyber callers favored KMM Group Ltd.’s plan for transforming a 100,000-square-foot building in Hatboro, Pa.,, into a high-end, high-capacity mission-critical manufacturing environment. The company said its new modernized facility will include 150-plus milling, turning, grinding, and EDM machines, 4,000 square feet of R&D space, an ISO Class 8 cleanroom, conference rooms equipped with NEAT technology, an employee gym, a modern cafeteria, quality control areas, an automation space, and professionally designed workspaces.
 
Denstply Sirona, not surprisingly, was popular among those with a penchant for business restructurings, as the company unveiled a board-approved strategy for improving operational performance and drive shareholder value creation. The restructuring plan calls for an 8%-10% workforce reduction, and implementation of five global business units that will be closely aligned to regional commercial structures. Central functions and infrastructure optimization will be undertaken to support efficiency, as well. Also, senior vice president of quality and regulatory role will be created to elevate the quality and regulatory affairs function in the management team, and the overall management structure will be simplified as well.

Asensus Surgical and Teleflex, meanwhile, easily won favor with website visitors for their new product revelations—the former for its LUNA robotic surgical platform, and the latter for FDA 510(k) clearance of its Triumph catheter.
 

1. Philips Recall of Previously Recalled, Repaired Ventilators Deemed Class I

2. KMM Group Announces Final Construction Phase for New Facility in Hatboro, PA

3. Dentsply Sirona to Implement Restructuring Effort

4. Asenus Surgical Reveals Next-Gen LUNA Robotic Surgical Platform

5. Teleflex Nabs FDA Nods for 2 Catheter Devices