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Recall Observatory FDA recall evidence

Core noun

Failure mode assignments

Deterministic labels derived from preserved recall-reason text.

Indexed record set

89,789 assignments

Page 3 of 3592

Mode Product Rule Evidence excerpt
Device software or design MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software. reason.device_software_design · v1.0.0 Cybersecurity vulnerability
Device software or design Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234) reason.device_software_design · v1.0.0 software version 10.0 may
Device software or design BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278 reason.device_software_design · v1.0.0 firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in
Device software or design BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx reason.device_software_design · v1.0.0 cybersecurity vulnerability
Device software or design illumina Model NextSeq 550 Dx REF 20005715 reason.device_software_design · v1.0.0 cybersecurity vulnerability
Device software or design BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software. reason.device_software_design · v1.0.0 software error
Device software or design Baxter Floor mounting column TS 7500 U, Product Code 1730732 reason.device_software_design · v1.0.0 software issue
Device software or design Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204 reason.device_software_design · v1.0.0 software issue
Device software or design Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 reason.device_software_design · v1.0.0 software version 10.0 may
Device software or design Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No reason.device_software_design · v1.0.0 Software issue
Device software or design Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)] reason.device_software_design · v1.0.0 software issue that causes an error
Device software or design Change Healthcare Radiology Solutions software version 14.2.2 reason.device_software_design · v1.0.0 software issue
Device software or design Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality reason.device_software_design · v1.0.0 software anomaly
Device software or design SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system reason.device_software_design · v1.0.0 software anomaly
Device software or design Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 reason.device_software_design · v1.0.0 software issue
Device software or design Baxter Stationary column TruSystem 7500 U, Product Code 1730731 reason.device_software_design · v1.0.0 software issue
Device software or design Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 reason.device_software_design · v1.0.0 software issue
Device software or design Baxter TruSystem 7500, Product Code 4091000 reason.device_software_design · v1.0.0 software issue

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