Medical device recalls

The table on certain Philips Azurion 5 M12 imaging systems may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This affects 326 units distributed worldwide, including 10 in the United States. No injuries have been reported.

Philips Azurion 7 M20 imaging systems may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This can occur under certain conditions across all software versions (R1.X, R2.X, R3.X). No injuries have been reported.

Philips medical imaging systems (Azurion 7 M12) may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. This affects certain software versions across multiple model numbers. No injuries have been reported.

Philips medical imaging systems (Azurion 7 B20) may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is supposed to be engaged. This affects certain software versions across three model numbers distributed worldwide.

The examination table on certain Philips Azurion 7 B12 X-ray imaging systems may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This could pose a safety risk to patients or staff during procedures. No injuries have been reported.

Philips medical imaging tables (Azurion 3 M15 systems) may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This affects specific model numbers with software versions R1.X, R2.X, and R3.X.

The table on certain Philips Azurion 3 M12 imaging systems may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. This could create a safety risk in clinical settings. Philips has identified this issue and is working on a solution.

Alphatec Spine has recalled a surgical instrument (ATEC Lateral Navigation Disc Prep Osteotome 10mm) used in spine surgery procedures. The instrument has a design defect where the connection to the Medtronic navigation tracking system does not fit correctly, which could affect its safe operation during surgery.

Alphatec Spine has recalled its ATEC Lateral Navigation Disc Prep Osteotome (10mm, model 266-01-000-10-N) used in spinal surgery due to an incorrect connection geometry in the navigated array. This defect could affect how the instrument connects to the Medtronic StealthStation navigation system during surgery. Seven units were distributed across 14 U.S. states.

Certain Laerdal Compact Suction Unit 4 RTCA models made during a specific time period may emit electromagnetic noise above acceptable levels for aircraft use. No injuries have been reported. The affected units have specific catalog numbers: 880052, 880062, or 881152.

Elekta's Leksell GammaPlan treatment planning software (versions 11.3 and 11.4) has a software error that could cause incorrect treatment location data if users do not properly update reference settings. This could result in radiation therapy being directed to the wrong location if the error goes undetected.

Elekta's Leksell GammaPlan software version 11.1 has a bug that can cause incorrect radiation targeting during Gamma Knife treatment planning. If users don't update an old reference point before creating a new treatment plan, the radiation may be aimed at the wrong location. This error may not be caught during normal review.

Halyard TRANSPORT BAG KIT (Kit Code LIFE0080-01) may have a defective Tyvek bag seal that could compromise the sterility of the kit. The issue affects approximately 1,500 units distributed in New Jersey. No injuries have been reported.

Straumann USA LLC recalled certain WB Impression Post Closed Tray kits because they contain magenta impression caps instead of the correct brown caps. This mix-up could lead to using the wrong component during dental implant procedures. The recall affects 561 units distributed nationwide.

Medline Industries is recalling specific lots of Mercy Circumcision Tray kits because the BD ChloraPrep Triple Swabsticks inside may have open or compromised seals on their packaging. This could affect the sterility of the applicators before use. No injuries have been reported so far.

Medline is recalling specific lots of sterile resuture packs (SKU DYNDL1980A) because the BD ChloraPrep swabsticks inside may have broken seals on their packaging. An open seal could allow the swabs to become contaminated. No injuries have been reported.

Medline is recalling nine different medical convenience kits that contain BD ChloraPrep Triple Swabsticks with potentially compromised packaging seals. The affected applicators may have open or damaged seals, which could allow contamination. About 8,445 kits are involved nationwide.

Medline is recalling specific lots of its blood culture kits because the BD ChloraPrep Triple Swabsticks inside may have damaged or open packaging seals. This could allow the applicators to dry out or become contaminated before use. The affected lots are 25EBU508 and 25EBE330.

Medline is recalling specific lots of suture removal kits that contain BD ChloraPrep Triple Swabsticks with potentially open or compromised packaging seals. An open seal on the applicators could allow contamination of the sterile product before use. No injuries have been reported.

Medline is recalling two medical convenience kits that contain BD ChloraPrep Triple Swabsticks with potentially open or compromised packaging seals. The affected kits are the POWERGLIDE DRESSING CHANGE KIT (SKU DYNDH1576, Lot 25EBP737) and CENTRAL LINE TRAY W/ CHLRP SWB (SKU RWM-DC57KC, Lot 25EBE082). An open seal could allow the sterile applicator to become contaminated.

Medline Industries is recalling 11 different medical kits that contain BD ChloraPrep Triple Swabsticks with potentially compromised packaging seals. The affected applicators may have open or broken seals, which could affect the sterility of the product. No injuries have been reported so far.

Medline is recalling eight types of medical convenience kits that contain BD ChloraPrep Triple Swabsticks with potentially opened or compromised seals. The affected kits are used in hospitals and medical settings for procedures involving central lines and ports. No injuries have been reported.

Medline Industries is recalling specific lots of Pediatric Cath Securement Kits (SKU DYNDC3108) because the BD ChloraPrep Triple Swabsticks inside may have open or compromised packaging seals. An open seal could allow the applicators to dry out or become contaminated before use.

Medline Industries is recalling specific lots of adult catheter securement kits (SKU DYNDC3109) because the BD ChloraPrep Triple Swabstick applicators inside may have broken seals on their packaging. This could allow the sterile applicator to become contaminated.

Medline Industries recalled specific lots of its Anesthesia Artline Pack kits because the BD ChloraPrep Triple Swabsticks inside may have open or compromised seals on the applicator packaging. An open seal could allow the sterilizing solution to dry out or become contaminated before use. No injuries have been reported.

Medline Industries is recalling certain lots of reprocessed Siemens ACUSON AcuNav ultrasound catheters because they may contain small particles of leftover material from reprocessing. If used, these particles could cause inflammation, infection, or blood clots that may lead to serious complications including stroke or pulmonary embolism.

Certain lots of reprocessed Biosense Webster SOUNDSTAR eco diagnostic ultrasound catheters may contain small particles of leftover material from manufacturing. If used, these particles could cause blood clots, infection, or other serious complications including stroke or lung embolism.

Medline Industries is recalling certain lots of reprocessed ViewFlex Xtra ICE Catheters (9F x 90cm) because they may contain small particles of leftover material inside the device. If used, these particles could trigger inflammation, infection, blood clots, or other serious complications.

Certain lots of reprocessed St. Jude Supreme and Response diagnostic electrophysiology catheters distributed by Medline may contain small particles of leftover material from reprocessing. If used in patients, these particles could cause blood clots, infection, or inflammatory reactions that may lead to serious complications including stroke or blood clots in the lungs or legs.

Medline Industries is recalling certain lots of reprocessed Livewire Steerable Electrophysiology Catheters because they may contain small particles of residual material left after reprocessing. If used, these particles could cause serious complications including infection, blood clots, or emboli.