Skip to content
Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1530 of 1581

Evidence Product Join Root cause
device-recall:cfres:173109 Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors Official recall number · Z-1771-2019 Software design
device-recall:cfres:173044 Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM Official recall number · Z-1815-2019 Process control
device-recall:cfres:172621 xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316. Official recall number · Z-1767-2019 Nonconforming Material/Component
device-recall:cfres:172957 Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA Official recall number · Z-1787-2019 Process control
device-recall:cfres:172972 Arrowg+ard Blue Advance JACC Product Code:CDC 42052 JX1A Official recall number · Z-1800-2019 Process control
device-recall:cfres:172968 Arrowg+ard Blue Advance JACC Product Code: CDC 41541 JX1A Official recall number · Z-1797-2019 Process control
device-recall:cfres:173043 Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM Official recall number · Z-1814-2019 Process control
device-recall:cfres:172567 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Official recall number · Z-1699-2019 Nonconforming Material/Component
device-recall:cfres:172409 Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539 Official recall number · Z-1500-2019 Device Design
device-recall:cfres:172511 Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097 Official recall number · Z-1576-2019 Device Design
device-recall:cfres:172520 Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350 Official recall number · Z-1585-2019 Device Design
device-recall:cfres:172793 Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01 Official recall number · Z-1638-2019 Device Design
device-recall:cfres:172433 Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791 Official recall number · Z-1517-2019 Device Design
device-recall:cfres:172548 Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368 Official recall number · Z-1612-2019 Device Design
device-recall:cfres:172423 Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20 Official recall number · Z-1376-2019 Device Design
device-recall:cfres:172446 Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845 Official recall number · Z-1529-2019 Device Design
device-recall:cfres:172760 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase 3 Femoral Drill Guide Extra Large Official recall number · Z-1739-2019 Nonconforming Material/Component
device-recall:cfres:172761 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small Official recall number · Z-1740-2019 Nonconforming Material/Component
device-recall:cfres:172370 Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 Official recall number · Z-1722-2019 Unavailable
device-recall:cfres:172728 Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand. Official recall number · Z-1731-2019 Incorrect or no expiration date
device-recall:cfres:172651 MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. Official recall number · Z-1743-2019 Nonconforming Material/Component
device-recall:cfres:172070 BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066 Official recall number · Z-1313-2019 Under Investigation by firm
device-recall:cfres:171782 ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills Official recall number · Z-1285-2019 Nonconforming Material/Component
device-recall:cfres:171330 VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents Official recall number · Z-1292-2019 Software design
device-recall:cfres:171676 ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. Official recall number · Z-1307-2019 Process control

Field note

Send feedback

We'll only use this to respond to your feedback.