Medical device recalls

Philips Medical Systems has identified a problem with the wired foot switch on certain Azurion 7 M12 X-ray imaging systems. When using the foot switch, X-ray imaging may not start or may start and stop intermittently. This affects approximately 1,994 systems sold worldwide, including 360 in the U.S.

Philips Medical Systems has identified a problem with the wired foot switch on certain Azurion 7 B20 X-ray imaging systems. The foot switch may fail to start X-ray imaging or cause imaging to stop and restart intermittently during use. This affects approximately 1,500 units worldwide, including about 320 in the United States.

Philips has identified a problem with the wired foot switch on certain Azurion 7 B12 X-ray imaging systems. The foot switch may fail to start X-ray imaging or may cause imaging to occur intermittently, which could affect clinical workflow. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain Azurion 3 M15 X-ray imaging systems where X-ray imaging may not start or may work intermittently. This affects specific serial numbers of the system manufactured by Philips Medical Systems Nederland B.V. and distributed worldwide.

Philips identified a problem with the wired foot switch on certain Azurion 3 M12 X-ray imaging systems. The foot switch may fail to start X-ray imaging or cause imaging to work intermittently. About 298 systems worldwide are affected, including 27 in the U.S.

Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/15 operating room tables. When using the foot switch, X-ray imaging may not start or may stop and start unexpectedly. This affects a small number of systems worldwide.

Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/15 X-ray imaging systems where the X-ray may not start or may start and stop unexpectedly. This affects 296 systems distributed worldwide, including 68 in the US. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/20 OR Tables where X-ray imaging may not start or may work intermittently. Five units have been affected outside the United States. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/20 X-ray imaging systems. The foot switch may fail to start X-ray imaging or cause imaging to work only intermittently, which could affect clinical procedures.

Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/10 X-ray systems that may prevent imaging from starting or cause it to work intermittently. This affects 85 systems worldwide, including 20 in the United States. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD10 operating room tables where X-ray imaging may not start or may work only intermittently. Two units worldwide are affected. No injuries have been reported.

Philips has found that the wired foot switch on certain ALLURA Xper FD20 operating room tables may fail to start X-ray imaging or may work only intermittently. This affects 4 units worldwide. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 surgical X-ray tables. The switch may fail to start X-ray imaging or may cause imaging to work only intermittently, which could disrupt surgical procedures. This affects 196 units worldwide.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 Biplane X-ray systems where imaging may not start or may work intermittently. This affects 461 units worldwide, including 198 in the US. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 X-ray systems where imaging may not start or may start intermittently. This affects specific serial numbers across three system codes. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD10/10 X-ray systems where imaging may not start or may work on and off intermittently. This affects 112 systems distributed worldwide, identified by specific serial numbers.

Philips has identified a defect in the wired foot switch on certain ALLURA Xper FD10 X-ray imaging systems that may prevent X-ray imaging from starting or cause it to work intermittently. This could delay or disrupt imaging procedures. Philips is working with healthcare facilities to resolve the issue.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD10F X-ray imaging systems. The foot switch may fail to start X-ray imaging or may cause imaging to work intermittently, which could affect clinical procedures. The issue affects 10 systems total, with no injuries reported.

Philips has identified a problem with the wired foot switch on certain Allura Xper FD10C X-ray imaging systems. When using the foot switch, X-ray imaging may not start or may start intermittently, which could affect clinical workflow. This affects a small number of systems worldwide.

BD Kiestra ReadA lab automation systems (Catalog No. 446948) may occasionally lose remote connectivity after a system reboot, which could temporarily delay plate retrieval from the incubator. The issue is intermittent and does not affect test results, assay performance, or sample integrity. This affects 82 units distributed across the United States and internationally.

Siemens has recalled certain lots of its Atellica CH A1c_E hemoglobin test kit because when used with another reagent (RCRP) on the same analyzer, the A1c test may give lower-than-accurate results. Lower results could delay diabetes diagnosis or lead to inadequate treatment. This issue does not affect labs using separate analyzers for each test.

RefleXion Medical's X1 Radiotherapy System has a software defect that can cause radiation treatment to be delivered to the wrong location when certain positioning corrections are made. This may result in radiation doses being delivered 5mm or more away from the intended target, with possible underdosing of 10% to 20%. The issue affects 12 systems running specific software versions.

ReCor Medical distributed 24 units of Paradise ultrasound renal denervation catheters (Model PRDS-068-02) that did not meet quality standards and were supposed to be destroyed, not sold. The devices were distributed in nine states: California, Colorado, Florida, Kansas, Missouri, North Carolina, Ohio, Texas, and Virginia. No injuries have been reported.

ReCor Medical distributed one Paradise ultrasound renal denervation catheter (Model PRDS-068-02, Lot M4907) that did not meet manufacturing standards and was supposed to be destroyed. The device was distributed in nine U.S. states. No injuries have been reported.

Philips Respironics has recalled certain Trilogy Evo Universal home ventilators (Software Version 1.05.15.00) because the obstruction alarm may not trigger as quickly as safety standards require. In some cases, the alarm could be delayed by up to four breaths, which may prevent timely notification of a breathing tube blockage.

Philips Respironics has recalled certain Trilogy EV300 home ventilators (software version 1.05.15.00) because the obstruction alarm may not trigger quickly enough if the breathing tube becomes blocked. In rare cases, the alarm could be delayed by up to four breaths, which is longer than safety standards allow.

Some Philips Respironics Trilogy Evo O2 ventilators with software version 1.05.15.00 may not sound an obstruction alarm quickly enough if the breathing tube becomes blocked. The alarm could be delayed by up to four breaths, which could reduce the time available to respond to a blockage.

Some Philips Respironics Trilogy Evo home ventilators with Software Version 1.05.15.00 may not sound their obstruction alarm quickly enough if the breathing tube becomes blocked. The alarm could be delayed by up to four breaths, which could reduce the time a user has to respond to an airway obstruction.

Baxter Healthcare has issued an urgent correction for the Blue Ventilator Adapter Module used with the Volara Respiratory Therapy system in home care settings. Patients or caregivers may not be aware of risks including dangerously low oxygen levels or lung injury from improper device use.

Abiomed's Impella Controller may display a delayed "Purge System Blocked" alarm when used with first-generation Impella 5.5 pumps. This could prevent timely detection of a blocked purge system. The issue affects 62 controllers with specific serial numbers in software versions 8.2.2 through 8.5.