This potential patient safety issue is only present in the following versions when a reverse workflow is used: 2004-R6.x, 5.10.x, 5.20, 5.25, 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, 8.30.0.  NOTE: The standard workflow is not impacted.  .

Radiology Devices

2

No

Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.

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

ISA CO2 Sensor serial numbers:  107349, 107357, 107358, 107363, 107370, 107377, 107390, 107407, 107435,  107476, 107509, 107510, 107556, 107659, 107700, 107707, 107768, 107776,  107831, 107832, 107836, 107839, and 107841.

Cardiovascular Devices

2

No

US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution.

Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.

Patient Data Module (PDM) V2 model: Serial numbers 10.03.XXXXX

Cardiovascular Devices

2

No

Distribution was nationwide to medical facilities. There was also military and government distribution.

The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

All Schiller PB-1000 PDM's distributed on or before 8/11/2016.

Cardiovascular Devices

2

No

Distribution US nationwide.

The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.

Version 11.0

Radiology Devices

2

No

US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.

DR Systems Unity PACS software, now known as Merge Unity PACS

Version 11.0

Radiology Devices

2

No

Distribution was made to medical facilities located in MT, CA, PA, and TX.

DR Systems Unity PACS software, now known as Merge Unity PACS software.

Recall of the eFilm workstation Medical Device Version 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3, and 4.1.

EFilm Workstation and eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1.

Radiology Devices

2

No

Worldwide Distribution - US: Nationwide including DC, GU, PR and Internationally to Canada, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Guatemala, hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritania, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.

Merge, eFilm Workstation and eFilm Lite || eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians

Model Catalog: EFILM01 (Lot serial: N/A)

EFILM WORKSTATION 4.0 AND EFILM WORKSTATION 4.0.1

Model Catalog: EFILM01 (Lot serial: >10 CONTACT MANUFACTURER)

eFilm Workstation/eFilm Lite

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Medical devices for diagnostics and radiation therapy

Diagnostic and therapeutic radiation products

Merge Healthcare: eFilm Workstation/eFilm Lite

2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4

MD: Radiology picture archiving and communication system workstation

Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine

Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine

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Merge: Eye Station

Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine