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Displaying 1 - 15 of 47 items.
Reddy-Dasatinib: out of specification
The dissolution is out of specification in the affected lot(s).
RecallHealth product recall | 2022-01-31
Ipela Fhd Ptz Tile Kits (Accessory) For Neuroworks/Sleepworks Software
The axis camera ceiling tile is not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. In these cases, modifications to the site's suspension grid or the natus ceiling tile might be required to provide…
RecallHealth product recall | 2022-01-31
Sensis Vibe
Under certain sporadic circumstances the Sensis Vibe Hemo System with VD12A software the Co (cardiac output) measurement using the thermodilution method will temporarily no longer be possible. This happens without any obvious reason. When the issue…
RecallHealth product recall | 2022-01-31
St80i Stress Test System
When patient demographic information is entered into the system and the patient information is saved or exported to a folder, in very rare situations, the demographic information that is displayed is that of the previous patient instead of the current…
RecallHealth product recall | 2022-01-31
Acuson Sequoia Diagnostic Ultrasound System
This update is specifically targeted to improve the robustness of the sequoia caster-assembly.
The front casters cannot fall of the Sequoia system, since the wheel locking/swivel control rod runs through the caster shaft. If the bolt comes out, the…
RecallHealth product recall | 2022-01-31
Sight Olo Products
A software defect was discovered, whereby in certain circumstances, a change to a reference range value that was canceled by the operator could nevertheless be saved, which may lead to incorrect reference range being set on the device. The software…
RecallHealth product recall | 2022-01-31
Acuson Juniper
Siemens Healthcare is notifying customer of a potential failure in the clip store function on the Acuson Juniper ultrasound system. In Juniper 1.0 the clip store function does not work when the ultrasound system has a disk full error. The purpose of this…
RecallHealth product recall | 2022-01-31
Medical Mask (Adult)
Reports received of a small hole or damage in the area of the maple leaf symbol in the corner of the healthy apparel disposable masks.
Recall start date: Jan 24, 2022
RecallHealth product recall | 2022-01-31
APO-AMITRIPTYLINE 10mg: NDMA impurity
Affected lots exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 36-month stability testing timepoint.
RecallHealth product recall | 2022-01-26
ELAVIL 10mg: NDMA impurity
Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 36-month stability testing timepoint.
RecallHealth product recall | 2022-01-26
Da Vinci Xi And X 12-8 Mm Cannula Reducer
There is the potential for the metal tip on the Da Vinci Xi And X 12-8 Mm Cannula Reducer (PN 470381-11) to get dislodged from the cannula reducer plastic shaft.
Recall start date: Dec 20, 2021
RecallHealth product recall | 2022-01-24
Minicap Extended Life Pd Transfer Set Clamps
Baxter Corporation is issuing an urgent medical device correction for the Minicap Extended Life Pd Transfer Sets. The following products may cause damage if they come into direct contact with the transfer set: Cleaning products such as hand sanitizer and…
RecallHealth product recall | 2022-01-24
Navitracker Kit A : Knee
Zimmer Biomet is conducting a medical device recall for one lot of the Navitracker Kit A : Knee product, which is a nonpatient contacting device used during computer and robotic assisted surgeries. The product in scope was released for distribution…
RecallHealth product recall | 2022-01-24
Pack,Hot/Cold,Curad,Retail W/Cov
The Curad Hot/Cold gel pack with wrap currently has the labeling states "does not contain natural rubber latex". However, the fabric around the gel pack does contain some natural rubber latex. The fabric wrap contains 20% latex thread. There is a risk of…
RecallHealth product recall | 2022-01-24
Liko M220 / M230 Mobile Lift
Hillrom received four (4) complaints between 29-Sep-2020 and 09-Apr-2021 of the Slingbar 450 becoming detached from the upper bracket of the Slingbar attachment on Liko M230 Mobile Lifts. The Slingbar is attached to the lifting arm through two brackets.…
RecallHealth product recall | 2022-01-24