There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
All Recalls
92,900 total recalls in our database
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Qiagen Sciences
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
The potential for cracks forming in the breathing circuit hose.
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Medtronic Neuromodulation
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Stryker
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Stryker Spine
Potential for the gold unlock button to separate from the inserter.
The potential for cracks forming in the breathing circuit hose.
The potential for cracks forming in the breathing circuit hose.
The potential for cracks forming in the breathing circuit hose.
Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Stryker Spine
Potential for the gold unlock button to separate from the inserter.
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Ethicon Endo Surgery
Identified curing issues with the silicone during the needles manufacturing process.
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
PDSIIΒΏVIOΒΏ30IN(75CM)ΒΏUSP6-0(M0.7)ΒΏD/AΒΏC-1
Ethicon Endo Surgery
Identified curing issues with the silicone during the needles manufacturing process.
The potential for cracks forming in the breathing circuit hose.
Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
Cordis US
product mix-up; Vascular stent labeled as one size but contains a different size.
Foldable Travel Hair Dryers
Unknown Manufacturer
The handheld hair dryers lack an immersion protection device that can cause death or serious injury due to electrocution or shock hazards if it falls into water when plugged in. The hair dryers are in violation of the federal regulations and present a substantial product hazard.
LVOE Hair Dryers
Unknown Manufacturer
The handheld hair dryers lack an immersion protection device and can cause death or serious injury due to electrocution or shock if they fall into water when plugged in. The hair dryers are in violation of the federal regulations and present a substantial product hazard.