Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc)
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that there is no potential harm to patients, onl
Class I - Dangerous
On August 6, 2012, Invacare voluntarily recalled the Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received.
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.
Class I - Dangerous
Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that there is no potential harm to patients, onl
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Philips Healthcare
Class I - Dangerous
Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivere
Class I - Dangerous
There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron
Class I - Dangerous
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw.
Class I - Dangerous
Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.
Class I - Dangerous
Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.
Class I - Dangerous
Reports of leaking during filling and administration.