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Fujifilm Mobile Digital X-Ray System FDR Nano
Fujifilm became aware that in rare cases, the arm base holding the tube section in DR-XD 1000 may get damaged. A protective hook will be attached to the equipment to prevent harm to patient even if the damage to the arm spreads. There have been no reported patient injuries associated with this issue. Recall start…
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Pentax Medical Video Processors
Under certain conditions, during endoscopic procedures using a combination of the Pentax Medical Video Processor EPK-I8020C and the Pentax Medical Video Upper GI Scope EG29-I20C, the observed image can become reddish or dark. Globally, Pentax has received 32 complaints related to this issue. The users have observed smoke-like steam and noted that the light guide…
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Assurity and Endurity Pacemakers
Abbott is informing clinicians of the potential for a device malfunction affecting a subset of Assurity™ and Endurity™ pacemakers. This issue may result in incomplete mixing of epoxy during manufacturing and, with time, may permit moisture ingress into the pulse generator header, introducing a risk of interrupting device functionality. Affected devices were manufactured between August…
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Synapse Picture Archiving And Communications Systems
Fujifilm became aware that a patient’s age for patients younger than 18 years of age can show incorrectly in the Synapse PACS Viewer eXtension (VX) client – image viewer. For instance, under these circumstances an infant patient’s actual age of 26 days may appear incorrectly as 5 days in Synapse VX. This issue affects Synapse…
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IntelePACS (Image Fusion Module)
An incorrect SUV (standard uptake value) calculation occurs in the PET/CT fusion viewer module. This issue only occurs on days with a DST (daylight savings time) change. The issue occurs because the calculation relies on a time calculation which does not correctly consider the DST change. An incorrect SUV may lead to an incorrect diagnosis.…
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Hamilton C2 and C3 Intensive Care Ventilators
This field safety notice (FSN) provides an updated information on Hamilton medical ventilators Hamilton-C2/C3: Hamilton Medical AG became aware of a malfunction with our Hamilton-C2/C3 ventilators when used long term in neonatal patients. If an affected device Hamilton-C2 or Hamilton-C3 is used accumulatively for 91 days in neonatal patient without a restart of the device,…
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MiniMed and Paradigm Insulin Pumps
When air pressure decreases (e.g., during flight takeoff), more insulin may be released than expected. Additionally, unintended insulin may be released even if the pump’s delivery is suspended or programmed to zero units per hour. When air pressure increases (e.g., during flight landing), less insulin may be released than expected. Recall Start Date: January 28,…