Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Class I - Dangerous
There is the potential for the length of the trocar shaft to be too long.
Class I - Dangerous
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.
Class I - Dangerous
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Siemens Healthcare Diagnostics
Class I - Dangerous
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
Class I - Dangerous
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Class I - Dangerous
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Medline Industries
Class I - Dangerous
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Knee and Humeral socket implants contain incorrect labeling.
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Olympus Corporation of the Americas
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Olympus Corporation of the Americas
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.