Ultrasound

Serial numbers 0001-0016, 0018-0035, 0037-0043, 0045-0048, 0050-0060, 0062-0064, 0066-0080, 0082-0157

Radiology Devices

2

No

Devices were distributed to 91 end users (hospitals, medical centers) and 2 distributors throughout the US. Foreign distribution included 3 distributors and 14 end users.

Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software - the change from TCD 100M to PMD 100 is a marketing change). Software version 1.3.0 || Model numbers 10119, 10863, 10919, 10968, 11016, 11052, 11090, 11091, 11235, 11236

Product Code 9001C0197. Lot numbers 61177, 61189, 61211, 61219, 61250, 61280, 61293, 61304, 63141, 63147, 63200, 63210, 63235, 63269, 63304, 63324, 63357, 63372, 63375, 63398, 63409, 63421, 63442, 63450, 63458, 63494, 63505, 63533, 63558, 63559, 63584, 63590, 63616, 63634, 63685, 63723, 63750, 63782, 63798, 63824, 63846, 63895, 63913, 63933, 63952, 63981, 64006, 64024, 64028, 64029, 64053, 64079, 64094, 64109, 64126, 64137, 64147, 64148, 64163, 64183, 64205, 64206, 64220, 64228, 64236, 64257, 64290, 64305, 64317, 64318, 64329, 64351, 64352, 64376, 64377, 64400, 64434, 64459, 64512, 64540, 64586, 64606, 64645, 64646,.

Radiology Devices

2

No

Nationwide. Foreign distribution to: Austria; Bahrain, Belgium, Bermuda, Brazil, Canada, Greece, Hong Kong, Italy, Japan, Kuwait, Malaysia, Mexico, Norway, Oman, Pakistan, Portugal, Qatar, Saudi Arabia, Switzerland, Turkey, United Arab Emirates, United Kingdom.

Site-Rite Sterile Ultrasound Probe Cover with Gel

Product Code 900023B01. Lot numbers 61233, 63200, 63235, 63263, 63270, 63324, 63357, 63375, 63401, 63409, 63414, 63451, 63458, 63515, 63530, 63559, 63612, 63615, 63646, 63674, 63770, 63824, 63875, 63953, 63998, 64080, 64191, 64258, 64269, 64289, 64317, 64493, 64586, 64646.

Radiology Devices

2

No

Nationwide. Foreign distribution to: Austria; Bahrain, Belgium, Bermuda, Brazil, Canada, Greece, Hong Kong, Italy, Japan, Kuwait, Malaysia, Mexico, Norway, Oman, Pakistan, Portugal, Qatar, Saudi Arabia, Switzerland, Turkey, United Arab Emirates, United Kingdom.

Intraoperative Ultrasound Cover Kit

All serial numbers.

Cardiovascular Devices

2

No

Domestic accounts: Boston University Medical Center, 88 E. Newton St., B-402, Boston, MA 02118; Criticor, 2943 Pullman St., Santa Ana, CA 92705; Ilex Medical, 370 Cypress Creek Circle, Olsmar, FL 34677; Peerless Medical Corp., 705 Summer Oak Dr., Ellisville, MO 63021; Rolomac International, 1836 NE 213 Ln., Miami FL, 33179; University of Miami, PO Box 01690 (R-114), Miami, FL 33101. Foreign accounts: Asia Health Care Co Ltc., 4 FL-3, No 601, Chung Cheng Rd., Taipei, Taiwan, R.O.C.; Century Medical Inc., 1-6-4 Osaki, Shinagawa-KU, Tokyo, Japan 141-8588; Farmplex Cardic, Sheldare Enterprises, Ltd., 20-22 Bedford Row, London, United Kingdom; Integmed Ltd., 51 Hung To Road Kwun Tong, Kowloon, Hong Kong; Reysas Medical Corp., Hulya Sokal No. 21 GOP, 06700 Ankara, Turkey; Rahn AG, Dorflistrasse 12, CH-8050, Zurici, Switzerland.

Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.