Part Number 04175-0008 and Part Number 13-00106-00

Cardiovascular Devices

2

No

Nationwide.

Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.

Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.

Radiology Devices

2

No

Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.

Fusion Workstation.; Indicated for the transmission and review of radiological images.

Merge: iConnect Enterprise Archive

Versions : 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.1 HF0557, 8.40.s, 8.40.2.1, 8.40.2.2, 8.80, 8.80.0.1, 8.80.1.1, 8.80.2, 8.80.0.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.1.2.2, 9.2.0, 9.3.0, 9.3.1, 9.4.0, 9.4.1, 9.4.2, 9.4.2.1., and 9.4.3

Radiology Devices

1

No

Distribution was made nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government/military distribution was also made.

iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.

Versions 5.30.0, 5.30.1,5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560, 5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30, 8.30.2, 8.40.0, 8.40.1 HF0557, 8.40.2, 8.40.2.1, 8.40.2.2, 8.70 - Now Obsolete, 8.80 and Share 2.1, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.2.0, 9.3.0, 9.3.1, 9.4, 9.4.1, 9.4.2, 9.4.2.1, and 9.4.3.

Radiology Devices

1

No

Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and military distribution was also made.

iConnect Enterprise Archive software.

The following lot numbers are affected and are not specific to each cable/sensor type:   09AP8, 10AEU, 10KBN, 09CF9, 10BMN, 10MDN, 09CNS, 10FEN, 10MDN, 09KG6, 10F95, 10DUT, 09KG6, 10F95, 10DDK, 09NMN, 10BMN, 10DUT, 10A81, 10GJB, 10KBS, 09NMN, 10BMN, 10DUT, 10AEU, 10GJB, 10KBS, 10AEU, 10KBN, 10KBS, 11AGS, 11KAJ, 11CFT, 10KFP, 11N61, 11DAY, 11AGS, 11NG2, 11CFT, 11AGS, 12CNX, 11DDK, 12FMH, 12C68, 11FBS, 12GEB, 12C68, 11JBK, 12GEB, and 12FMH.

Anesthesiology Devices

2

No

Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.

MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), || Product Usage: || Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.

The following lot numbers are affected and are not specific to each cable/sensor type:   09AP8, 10AEU, 10KBN, 09CF9, 10BMN, 10MDN, 09CNS, 10FEN, 10MDN, 09KG6, 10F95, 10DUT, 09KG6, 10F95, 10DDK, 09NMN, 10BMN, 10DUT, 10A81, 10GJB, 10KBS, 09NMN, 10BMN, 10DUT, 10AEU, 10GJB, 10KBS, 10AEU, 10KBN, 10KBS, 11AGS, 11KAJ, 11CFT, 10KFP, 11N61, 11DAY, 11AGS, 11NG2, 11CFT, 11AGS, 12CNX, 11DDK, 12FMH, 12C68, 11FBS, 12GEB, 12C68, 11JBK, 12GEB, and 12FMH.

Anesthesiology Devices

2

No

Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.

MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), || Product Usage: || Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.

The following lot numbers are affected and are not specific to each cable/sensor type:   09AP8, 10AEU, 10KBN, 09CF9, 10BMN, 10MDN, 09CNS, 10FEN, 10MDN, 09KG6, 10F95, 10DUT, 09KG6, 10F95, 10DDK, 09NMN, 10BMN, 10DUT, 10A81, 10GJB, 10KBS, 09NMN, 10BMN, 10DUT, 10AEU, 10GJB, 10KBS, 10AEU, 10KBN, 10KBS, 11AGS, 11KAJ, 11CFT, 10KFP, 11N61, 11DAY, 11AGS, 11NG2, 11CFT, 11AGS, 12CNX, 11DDK, 12FMH, 12C68, 11FBS, 12GEB, 12C68, 11JBK, 12GEB, and 12FMH.

Cardiovascular Devices

2

No

Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.

SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), || Product Usage: || Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.

The following lot numbers are affected and are not specific to each cable/sensor type:   09AP8, 10AEU, 10KBN, 09CF9, 10BMN, 10MDN, 09CNS, 10FEN, 10MDN, 09KG6, 10F95, 10DUT, 09KG6, 10F95, 10DDK, 09NMN, 10BMN, 10DUT, 10A81, 10GJB, 10KBS, 09NMN, 10BMN, 10DUT, 10AEU, 10GJB, 10KBS, 10AEU, 10KBN, 10KBS, 11AGS, 11KAJ, 11CFT, 10KFP, 11N61, 11DAY, 11AGS, 11NG2, 11CFT, 11AGS, 12CNX, 11DDK, 12FMH, 12C68, 11FBS, 12GEB, 12C68, 11JBK, 12GEB, and 12FMH.

Anesthesiology Devices

2

No

Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.

Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), || Product Usage: || Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.

Merge: Merge CADstream

Version 9.0.9 and earlier using EchoIMS.

Radiology Devices

2

No

US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.

Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, and 10.0.

Radiology Devices

2

No

Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.

Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, and 9.0.8

Radiology Devices

2

No

US Nationwide Distribution.

Merge Cardio software. || Product Usage: || Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.

Radiology Devices

2

No

Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. || Intended to be used to acquire, store, print, transfer, and archive clinical information.

Versions 9.0; 9.0.1; 9.0.2; 9.0.3; 9.0.4; 9.0.5; 9.0.6; 9.0.7, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2.

Radiology Devices

2

No

Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government distribution.

Merge Cardio software.

Versions 8.30, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 10.0, 10.0.1, and 10.1 with Issuer of Patient ID (IPID)

Radiology Devices

2

No

US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. There was no foreign/government/military distribution.

Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

Merge Cardio with software version 10.1 LA.  Merge Cardio is intended to allow users to review diagnostic and non-diagnostic quality images.

Radiology Devices

2

No

Distributed in the states of IL, NC, and VT.

Merge Cardio with software version 10.1 LA.

Model Catalog: MERGE EYE CARE PACS (Lot serial: >10 CONTACT MANUFACTURER)

MERGE EYE CARE PACS

Model Catalog: MERGE EYE CARE PACS (Lot serial: 1.1.3); Model Catalog: MERGE EYE CARE PACS (Lot serial: 1.1.2); Model Catalog: MERGE EYE CARE PACS (Lot serial: 1.0); Model Catalog: MERGE EYE CARE PACS (Lot serial: 1.1); Model Catalog: MERGE EYE CARE PACS (Lot serial: 1.1.1)

MERGE EYE STATION IMPORT UTILITY

Model Catalog: MERGE EYE CARE PACS (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: MERGE EYE STATION (Lot serial: >10 CONTACT MANUFACTURER)

MERGE EYE CARE PACS;MERGE EYE STATION

All versions of Eye Care PACS, Eye Station, and ESIU.

Ophthalmic Devices

2

No

Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution.

Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).