Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Chest Drainage Units and Accessories: Product Code Description 1. 88885715...
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material N...
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. M...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Fixone Biocomposite Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
BEAR Implant. Model Number: 1000.
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet S...
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape M...
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit ...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical...
BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PA...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR ...
The console label for affected devices is missing the "DANGER" symbol.
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX1...
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A ...
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: ...
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT2...
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number:...
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5,...
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ...
Inflation device handle may detach from the syringe during procedure.
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Ph...
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Mazor X robotic guidance system REF: TPL0059
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.