Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
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- Evidence
- device-recall:cfres:197680
- Product
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
- Join
- Official recall number ·
Z-1024-2023 - Root cause
- Process change control
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- Evidence
- device-recall:cfres:197607
- Product
- Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
- Join
- Official recall number ·
Z-1019-2023 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:197682
- Product
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
- Join
- Official recall number ·
Z-1026-2023 - Root cause
- Process change control
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- Evidence
- device-recall:cfres:197510
- Product
- TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
- Join
- Official recall number ·
Z-1107-2023 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:198009
- Product
- Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
- Join
- Official recall number ·
Z-1109-2023 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:198117
- Product
- WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
- Join
- Official recall number ·
Z-1102-2023 - Root cause
- Process design
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- Evidence
- device-recall:cfres:197850
- Product
- Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
- Join
- Official recall number ·
Z-1083-2023 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:197870
- Product
- Identity Shoulder System Resection Planer 35mm Resection Planer
- Join
- Official recall number ·
Z-1098-2023 - Root cause
- Process control
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- Evidence
- device-recall:cfres:198463
- Product
- stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
- Join
- Official recall number ·
Z-1191-2023 - Root cause
- Process change control
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- Evidence
- device-recall:cfres:198299
- Product
- Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
- Join
- Official recall number ·
Z-1192-2023 - Root cause
- Software Design Change
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- Evidence
- device-recall:cfres:198347
- Product
- CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
- Join
- Official recall number ·
Z-1219-2023 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:198578
- Product
- DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).
- Join
- Official recall number ·
Z-1206-2023 - Root cause
- Software design
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- Evidence
- device-recall:cfres:197448
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
- Join
- Official recall number ·
Z-0968-2023 - Root cause
- Unknown/Undetermined by firm
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- Evidence
- device-recall:cfres:197469
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
- Join
- Official recall number ·
Z-0983-2023 - Root cause
- Unknown/Undetermined by firm
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- Evidence
- device-recall:cfres:197192
- Product
- Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
- Join
- Official recall number ·
Z-0886-2023 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:197595
- Product
- AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
- Join
- Official recall number ·
Z-1000-2023 - Root cause
- Process control
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- Evidence
- device-recall:cfres:197191
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-32, 0998-UC-0800-33, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55, 0998-UC-0800-65.
- Join
- Official recall number ·
Z-0885-2023 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:197471
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
- Join
- Official recall number ·
Z-0985-2023 - Root cause
- Unknown/Undetermined by firm
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- Evidence
- device-recall:cfres:197597
- Product
- Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
- Join
- Official recall number ·
Z-1002-2023 - Root cause
- Process control
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- Evidence
- device-recall:cfres:198078
- Product
- Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
- Join
- Official recall number ·
Z-1139-2023 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:197524
- Product
- Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
- Join
- Official recall number ·
Z-1177-2023 - Root cause
- Packaging process control
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- Evidence
- device-recall:cfres:198057
- Product
- BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
- Join
- Official recall number ·
Z-1244-2023 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:198321
- Product
- Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
- Join
- Official recall number ·
Z-1148-2023 - Root cause
- Software design
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- Evidence
- device-recall:cfres:198323
- Product
- CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
- Join
- Official recall number ·
Z-1223-2023 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:198055
- Product
- BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329461
- Join
- Official recall number ·
Z-1242-2023 - Root cause
- Under Investigation by firm