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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 1544 of 1581

Evidence Product Join Root cause
device-recall:cfres:142336 Syngo Imaging XS is a Picture Archiving and Communication System (PACS) Official recall number · Z-0550-2016 Software in the Use Environment
device-recall:cfres:141887 DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D Official recall number · Z-0493-2016 Nonconforming Material/Component
device-recall:cfres:141933 ProScreen 12 Panel Dip Card, Item No. PSD-12BUP Official recall number · Z-0522-2016 Nonconforming Material/Component
device-recall:cfres:141907 Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W Official recall number · Z-0509-2016 Nonconforming Material/Component
device-recall:cfres:142352 Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700. Official recall number · Z-0552-2016 Nonconforming Material/Component
device-recall:cfres:141894 DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D Official recall number · Z-0500-2016 Nonconforming Material/Component
device-recall:cfres:141821 1 Step 12 Panel Cup, Item No. NBCA-12M-W Official recall number · Z-0484-2016 Nonconforming Material/Component
device-recall:cfres:142158 Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. Official recall number · Z-0441-2016 Process change control
device-recall:cfres:141932 ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M Official recall number · Z-0521-2016 Nonconforming Material/Component
device-recall:cfres:141880 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA Official recall number · Z-0487-2016 Nonconforming Material/Component
device-recall:cfres:141136 ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature. Official recall number · Z-0207-2016 Unknown/Undetermined by firm
device-recall:cfres:140308 Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images. Official recall number · Z-0218-2016 Software design
device-recall:cfres:140495 e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. Official recall number · Z-0208-2016 Component design/selection
device-recall:cfres:140259 VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest. Official recall number · Z-0231-2016 Software design
device-recall:cfres:141165 The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants. Official recall number · Z-0225-2016 Software design
device-recall:cfres:139626 R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical. Official recall number · Z-0245-2016 Unknown/Undetermined by firm
device-recall:cfres:139657 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili Official recall number · Z-2813-2015 Process control
device-recall:cfres:139841 regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Official recall number · Z-0088-2016 Process control
device-recall:cfres:139635 Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Official recall number · Z-2756-2015 Device Design
device-recall:cfres:139628 Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Official recall number · Z-2750-2015 Device Design
device-recall:cfres:139633 Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Official recall number · Z-2754-2015 Device Design
device-recall:cfres:139850 regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Official recall number · Z-0096-2016 Process control
device-recall:cfres:139846 regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Official recall number · Z-0092-2016 Process control
device-recall:cfres:139825 regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Official recall number · Z-0079-2016 Process control
device-recall:cfres:139762 regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Official recall number · Z-0045-2016 Process control

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