Device Recall Axiom Sensis

Software Version VD10B

Cardiovascular Devices

2

No

US Distribution to the states of : IN, MI, IA

Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,

Serial Numbers 1002, 1034, 1100-1253, 1300-1504

Cardiovascular Devices

2

No

The product was shipped to 43 medical facilities nationwide and one government account in KY.

AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637

Serial numbers: 11001-11014, 11016, 11018, and 11050-11054.

Cardiovascular Devices

2

No

The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.

AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161

Serial numbers: 1155, 6002, 6006-6014, 6016, 6018-6021, 6023-6025, 6027-6053, and 6100-6125. Model number 66 34 641 involves the following serial numbers: 4001-4008 and 4050-4056. Model number 66 34 658 involves the following serial numbers: 8001-8003, 8006-8007, 8009-8010, and 8050-8055. Model number 66 48 161 involves the following serial numbers: 11001-11014, 11016, 11018, and 11050-11054.

Cardiovascular Devices

2

No

The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.

AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.

Serial numbers: 2001-2011, 2013-2023, 2025-2026, 2028, 2031-2067, 2069-2090, 2092-2132, 2134-2143, 2145-2148, 2150-2158, 2160-2260, 2262, and 2265-2266

Cardiovascular Devices

2

No

The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.

AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.