Class I - Dangerous
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Ion Beam Applications S.A.
Class I - Dangerous
A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
Class I - Dangerous
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
Ortho-Clinical Diagnostics
Class I - Dangerous
Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the communication between enGen TCAutomation (TCA) Bypass modules (manufactured by Thermo-Fisher Scientific) and the VITROS Analyzers. To date, no occurrences of this issue have been observed on Orthos enGen(TM) Systems. Sample IDs may become miss-associated with the actual sample being processed due to discrepant information passed to the analyzer through InOut communication device, triggered by a specific set of events occurring between the Bypass module and the analyzer. --- All of the following conditions must be present for the issue to potentially occur: (1.) The Bypass module is in the process of positioning Sample A at the aspiration position, and (2.) At least two additional sample tubes (Samples B and C) are waiting to be aspirated in the Bypass module queue, and (3.) A Radio Frequency Identification (RFID) Tag Read failure occurs on the Sample A carrier, and (4.) The VITROS System is not available to aspirate on the track (for example, the analyzer is initializing, or the user is making entries on the diagnostic screen, or samples are being aspirated from the front of the analyzer, etc.). --- If the software anomaly occurs and the issue is present, the Sample ID in the INOUT communication device software queue becomes asynchronous with the actual Sample ID physical queue, and the VITROS assay result will be reported for the wrong Sample ID. All subsequent samples will have miss-associated results until the Bypass module is reset or the queue is empty. --- This issue could potentially miss-associate a sample/patient ID with a test result of a different sample. Depending on the test involved, patients health condition, etc., the potential health risk posed to the affected patient could range from no risk to serious risk, and potentially could lead to misdiagnosis or inappropriate medical intervention. To date, no patient harm was reported related to this product issue.
Class I - Dangerous
Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.
Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization, and may lead to a discrepancy in dose calculation between this version of Mobius3D (1.5.0) and the prior version (1.4.2), where none should have been expected.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Class I - Dangerous
Product shipped proximate to or past the expiration date listed on the product label.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Keyless Driver Product Usage: Pneumatic system
The Anspach Effort
Class I - Dangerous
Supplied Directions for Use (DFU) did not contain a recommended service interval.
16CM MIN INVASIVE ATTACH, BLACK MAX
The Anspach Effort
Class I - Dangerous
Supplied Directions for Use (DFU) did not contain a recommended service interval.
ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
KEYLESS DRIVER, BLACK MAX
The Anspach Effort
Class I - Dangerous
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Minimal Access Straight Driver Product Usage: Pneumatic system
The Anspach Effort
Class I - Dangerous
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Chuck Driver System
The Anspach Effort
Class I - Dangerous
Supplied Directions for Use (DFU) did not contain a recommended service interval.
16cm Minimally Invasive Attachment Product Usage: Pneumatic system
The Anspach Effort
Class I - Dangerous
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Class I - Dangerous
Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown.