The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
MicroAire K-Wires
MicroAire Surgical Instruments
Class I - Dangerous
Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).
MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA
Class I - Dangerous
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA
Class I - Dangerous
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA
Class I - Dangerous
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
Class I - Dangerous
Sterility compromised due to breach in sterile barrier
A-series lift - A625 Manual Part No. 324117. Prism Medical.
ErgoSafe Products, LLC (DBA) Prism Medical
Class I - Dangerous
During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Merge PACS software. The firm name on the label is Merge Healthcare.
Merge Healthcare
Class I - Dangerous
Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
Class I - Dangerous
DHEA-S causes falsely elevated progesterone results.
Class I - Dangerous
DHEA-S causes falsely elevated progesterone results.
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Class I - Dangerous
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process.
The UNI-CP System; Model Number: 330230SND.
Integra LifeSciences
Class I - Dangerous
The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.
Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Villa Sistemi Medicali S.P.A.
Class I - Dangerous
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA
Class I - Dangerous
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA
Class I - Dangerous
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare
Class I - Dangerous
When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.