LEONI CIA CABLE SYSTEMS - ORION System - Class 2 Recall
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2023 Category: Medical Devices Source Type: alerts
LEONI CIA CABLE SYSTEMS - ORION System - Class 2 Recall
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2023 Category: Medical Devices Source Type: alerts
CHANGE HEALTHCARE CANADA COMPANY - Class 2 Recall
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Custom Sterile and NonSterile Procedural Kits containing Turkuaz Ultrasound Gel - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERV...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G; d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C; e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567; f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N; g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880; h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D; e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747; f. PERIPHERAL PACK, Model Number: DYNJ44960D; g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865; h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B; i. PERMACATH-LF, Model Number: DYNJ42262D; j. PHLEBEC...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165; d. 3" RADIAL ARTERIAL LINE KIT, Model Number: ART240A; e. 6" FEMORAL ARTERIAL LINE KIT, Model Number: ART245A, ART245B; f. A LINE TRAY, Model Number: ART690; g. A-LINE INSERTION TRAY, Model Number: ART645; h. AMNIOCENTESIS TRAY, Model Number: MNS8750; i. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570A; j. ...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C; d. OPEN HEART PACK A B, Model Number: DYNJ53984G; e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G; f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N; g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W; h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYN...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Custom Sterile and NonSterile Procedural Kits containing Turkuaz Ultrasound Gel - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRAPHY PACK, Model Number: DYNJ65963; e. ANGIOPLASTY PACK-LF, Model Number: DYNJ64655; f. ARTHROGRAM TRAY, Model Number: SPEC0232; g. BASIC CATH/ANGIO, Model Number: DYNJ62591A; h. BASIC PACK, Model Number: DYNJ39752A; i. C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B; j. CATH ANGIO PACK, Model Number: DYNJ64050; k. DBD-KIT NEURO CAROTID SET...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US; h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A; i. MULTIMED 7FR 3L 20...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Medline Probe Cover Kits - Class 2 Recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR CDS, Model Number CDS983394I; e. ENDOVASCULAR CDS, Model Number CDS983394J; f. ENDOVASCULAR CDS, Model Number CDS983394K; g. OPEN HEART CDS, Model Number CDS983513F; h. OPEN HEART ANESTHESIA PACK, Model Number CDS983849D; i. OPEN HEART ANESTHESIA PACK, Model Number CDS983849F; j. VNUS, Model Number CDS984292I; k. OPEN HEART CDS, Model Number CDS984355G...
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Medline Probe Cover Kits - Class 2 Recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338; i) BLOCK KIT-LF, Model Number DYNJRA1287A; j) BLOCK KIT-LF, Model Number PAIN1622A; k) BLOCK KIT-L...
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Medline Probe Cover Kits - Class 2 Recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model Number IVS3300; e) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A; f) EPIV PROCEDURE TRAY, Model Number IVS3825; g) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A; h) RADIOLOGY TRAY, Model Number MNS11625; i) BEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A; j) NGHS EVOR ANGIO PACK, Model Number NG410A; k) PICC INSERT KIT-LESS THAN 3 FR,...
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Medline Probe Cover Kits - Class 2 Recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0149444N; e) DIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G; f) PICC LINE PACK-LF, Model Number DYNJ0275614F; g) ANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M; h) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V; i) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W; j) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X; k) ANGIO PACK-LF, Mode...
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Medline Probe Cover Kits - Class 2 Recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; b) DBS PACK-LF, Model Number DYNJ0878178J; c) DBS PACK-LF, Model Number DYNJ0878178K; d) NEURO ARTERIOGRAM PACK-LF, Model Number DYNJ0948060F; e) NEURO IR PACK, Model Number DYNJ35066I; f) NEURO IR PACK, Model Number DYNJ35066J; g) IR NEURO PACK, Model Number DYNJ39198L; h) IR NEURO PACK, Model Number DYNJ39198N; i) BASIC PACK, Model Number DYNJ39752A; j) C.I.C.N. ANGIO PACK, Model Number DYNJ53064B; k) ANGIOGRAPHIC PACK, Model Number DYNJ57442C; l) ANGIO/VENO PACK, Mod...
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
