Topic archive
MedTech Current publications and recall entries tagged Diagnostic Imaging.
Philips is correcting Lumify use instructions after unexpected transducer re-registration and unstable USB connections could prevent or interrupt scanning. FDA's October 19 communication confirms Class I recall status; the correction does not involve removing devices.
Health Canada has classified the recall of Philips Lumify portable ultrasound systems as Type I after software-related transducer re-registration failures and unstable USB connections were found to prevent or interrupt scanning and delay patient care.
The software failure can change radiation delivered during a scan, beyond disrupting system availability. Imaging departments must manage the affected workflow while the correction is arranged. For software-quality teams, it shows how failure to stop a scan sequence can become a radiation-control problem.
Image artifacts and wrong slice thickness can affect interpretation; unintended motion also concerns system behavior. Radiology, clinical engineering, and software change-control teams need the instructions for this event. It remains separate from the Bolus Tracking recall because its failure modes and corrective instructions differ.
MHRA’s September MRI guidance update corrects diagrams and other details; the fifth-edition rewrite was introduced in July. The current guidance explains distinct questions about 7 T heating and implants, hearing-protection ratings and quench venting, rather than a single new September safety regime.
Images associated with the wrong patient can mislead clinical interpretation even when the image itself is valid. Imaging and hospital IT teams should account for the Study ID risk before changing worklist, interface, or system configurations.
Incorrect patient association is a data-integrity failure with direct diagnostic implications even when the underlying images themselves are unchanged. The recall is also operationally significant because healthcare organizations may need to preserve legacy systems, pause new DICOM migration work, and verify migrated studies against patient identifiers while awaiting correction.
Doppler measurements can influence vascular and hemodynamic assessment, so a mismatch between displayed and actual sample location has direct diagnostic relevance. The correction also illustrates how a software-design change can alter measurement interpretation while the device remains usable under specific interim restrictions communicated to clinical users.
The US FDA has issued a final order denying an industry petition seeking partial 510(k) premarket notification exemptions for radiology CADe, CADx, and CADt software devices under 21 CFR Part 892.
A radiation-related field correction across several CT platforms has broad relevance for imaging departments, service organizations, and device quality teams. The shared software-correction approach also makes grouping appropriate: readers can understand one underlying field action without losing the individual model families, recall numbers, or source records.
A mechanical issue in a ceiling-suspended interventional imaging system can interrupt procedures and requires prompt recognition of warning signs. Although only 10 systems are listed, the event is professionally relevant because it combines procedural imaging, mechanical hardware, stop-use criteria, and a service-based inspection and correction program.
Measurement accuracy is central to diagnostic imaging workflows, so even a small installed base can justify attention when software may alter a displayed measurement. The correction also illustrates a common software-field-action pattern: users may continue operating the system when they understand the limitation and apply an approved workaround.
Measurement errors in a diagnostic imaging workstation can affect interpretation even when source images remain available. The mitigation combines retrospective study identification, cross-checking against modality measurements, and a software update.
Bolus Tracking coordinates contrast enhancement with CT image acquisition, so failure to trigger the clinical scan can disrupt an imaging workflow at a critical step. The event also demonstrates a software correction handled under radiation-product requirements, making it relevant to both imaging-service operations and regulatory teams responsible for radiological systems.
Azurion systems support image-guided interventional procedures, so software failures affecting both imaging and equipment movement can create immediate procedural and workflow consequences. Grouping the two FDA records also illustrates why product-version records with substantially identical failure modes and corrective instructions should be treated as one editorial event.
Loss of geometry movement in an interventional fluoroscopic system can disrupt procedure workflow even when imaging remains available. The event is relevant to hospitals because the permanent correction is a future software installation, requiring users to retain and post interim instructions, recognize the failure mode, and use the specified restart process meanwhile.