Medical device recalls

Sedecal reminded users that its 40KWFX mobile X-ray systems are not water-resistant and must be cleaned strictly according to the manual instructions. Improper cleaning could damage the equipment. This notice affects 55 units distributed in California, Illinois, and New Jersey.

Sedecal is reminding users that the MobileDiagnost wDR 2.2 mobile X-ray system is not water-resistant. Improper cleaning can damage the equipment and may affect its safety and performance. Users must follow the cleaning instructions in the equipment manual.

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Philips Zenition 50 interventional X-ray systems may experience loss of imaging ability or degraded image quality over time due to corrosion of an internal control board. The issue affects 29 units distributed across multiple countries including the United States.

Unauthorized actors accessed product service credentials used by some BD technical support teams. This creates a risk that diagnostic test data and system information could be accessed, changed, or made unavailable until BD updates these credentials.

Unauthorized actors gained access to service credentials used by BD technical support teams to access the BD Phoenix M50 Automated Microbiology System. Until these credentials are updated, there is a risk that unauthorized individuals could access the system and view, modify, or disrupt patient data and system function.

Support service credentials for some BD MAX diagnostic systems were accessed by an unauthorized person. Until BD updates these credentials, there is a risk that someone could gain unauthorized access to the system and the data it contains.

Unauthorized actors gained access to service credentials used by BD technical support teams for the BACTEC 9120 blood culture system. Until credentials are updated, there is a risk that unauthorized parties could access the system or associated patient data.

Unauthorized actors accessed service credentials used by BD technical support teams to maintain certain BACTEC blood culture instruments. This could allow unauthorized access to affected devices and the patient data they contain until BD updates these credentials.

Service credentials used by BD technical support teams were accessed by an unauthorized person. Until BD updates these credentials, there is a risk that someone could gain unauthorized access to the system and its data.

Medline Industries identified a limited quantity of prefilled saline flush syringes (0.9% Sodium Chloride Injection, USP, 10 mL) that may not contain the correct concentration of sodium chloride. The affected syringes were distributed nationwide in the US and Canada.

Some Welch Allyn SureTemp Plus thermometer oral probes were incorrectly programmed with rectal probe settings. These affected probes may display temperatures that are lower than actual body temperature, which could delay treatment of fever or infection.

Tandem Diabetes Care insulin pumps (t:slim X2 and Mobi models) with certain software versions may deliver an unexpected automatic insulin correction dose when paired with a Dexcom G7 sensor. This could cause low blood sugar (hypoglycemia). The issue affects specific software versions: t:slim X2 versions 7.9.0.1 and 7.10.1, and Mobi version 7.9.0.1.

If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.

Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

Due to incorrect/lack of Unique Device Identifier (UDI) codes.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.