CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment
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FDA
Z-1553-2026
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Medical Device |
High |
Mar 18, 2026
Recall: Jan 30, 2026
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Details |
GEM Premier 5000 PAK, Part No. 00055360004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
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FDA
Z-1524-2026
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Medical Device |
High |
Mar 18, 2026
Recall: Jan 20, 2026
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Details |
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FDA
Z-1428-2026
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Medical Device |
High |
Feb 25, 2026
Recall: Nov 17, 2025
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Details |
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FDA
Z-1360-2026
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Medical Device |
High |
Feb 18, 2026
Recall: Jan 20, 2023
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Details |
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FDA
Z-1356-2026
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Medical Device |
High |
Feb 18, 2026
Recall: Jan 20, 2023
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Details |
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FDA
Z-1357-2026
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Medical Device |
High |
Feb 18, 2026
Recall: Jan 20, 2023
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Details |
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FDA
Z-1358-2026
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Medical Device |
High |
Feb 18, 2026
Recall: Jan 20, 2023
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Details |
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FDA
Z-1359-2026
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Medical Device |
High |
Feb 18, 2026
Recall: Jan 20, 2023
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Details |
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FDA
Z-1238-2026
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Medical Device |
High |
Feb 11, 2026
Recall: Nov 2, 2025
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Details |
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
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FDA
Z-1217-2026
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Medical Device |
High |
Feb 4, 2026
Recall: Nov 6, 2025
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Details |
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
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FDA
Z-1147-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1145-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1141-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1148-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1150-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1144-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1152-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1143-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1154-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1146-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1149-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1153-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1151-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1142-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |
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FDA
Z-1140-2026
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Medical Device |
High |
Jan 28, 2026
Recall: Oct 24, 2025
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Details |