This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. It contains all software and computer related recall excerpts for the years listed. Some of the newest recalls on the site may not be included. This compilation is provided in reverse chronological order and is useful for quick review,...Read More

Company: Illumina Inc.Date of Enforcement Report 12/31/2014 Class lII: PRODUCT Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform. Recall Number Z-0850-2015 REASON Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the...Read More

Company: Illumina Inc.Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries....Read More

Company:Horiba Instruments Inc.Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC) results from an ABX...Read More

Company: GE Healthcare It. Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have...Read More

/docs/FDARadiationBiodosimetryDevicesDraft.pdfRead More

Company: Bausch & Lomb Incorporated Rochester, NY Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal...Read More

Company: Bausch & Lomb Incorporated Rochester, NY Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal...Read More

Company: Bausch & Lomb Incorporated Rochester, NY Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY Recall Number Z-0862-2015 REASON A software anomaly was identified where the system may automatically transition from “Standby” to “Ready to Fire”...Read More

Company: on Beam Applications S.A.Date of Enforcement Report 12/31/2014 Class lI: PRODUCT adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device....Read More