FDA Device

Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.

Hazard

Potential inaccurate printed information in the upper and lower margins of a print strip.

What You Should Do

Remedy

Datascope initiated this field action in February, 2004. Datascope Service Representatives are visiting the customers and doing the retrofit.

Products

Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.
Brand
Datascope Corp
UPC
Serial Numbers: CM16830-E2; CM17664-C3; CM02100-D0; CM21267-B3; CM01262-B0; CM17728-F3; CM14167-L1; CM15062-B2; TM05314-D3; TM03604-A3; TM03630-A3; TM03642-A3; TM04059-B3; CM11122-F1; CM02057-D0; CM10756-F1; CM01376-B0; CM06107-K0; CM08770-C1; CM04116-H0; CM03838-G0; CM15058-B2; CM10359-F1; TM04721-C3; CM03958-G0; CM12388-I1; CM11462-G1; TM04175-B3; CM04386-H0; CM04445-H0; CM12571-I1; CM12778-I1; CM11479-G1; CM11776-H1; CM03556-F0; CM17319-E2; TM03982-A3; CM10360-F1; CM13887-K1; TM06058-F3; CM07526-B1; CM17683-F3; CM17715-F3; CM14479-A2; CM04265-H0; CM04703-I0; CM16756-E2; TM04809-C3; TM01569-H2; TM03602-A3; TM03603-A3; TM04091-B3; CM14979-B2; CM14986-B2; CM09445-D1; CM09479-D1; CM09935-E1; CM10117-E1; CM16268-D2; CM16451-D2; CM16540-D2; CM20116-F2; CM20117-F2; CM20130-F2; CM20160-F2; CM20196-F2; CM20203-F2; CM20216-F2; CM20218-F2; CM20219-F2; CM20220-F2; CM20221-F2; CM20529-F2; CM20531-F2; CM20533-F2; CM20537-F2; CM20538-F2; TM03635-A3; TM03639-A3; TM03647-A3; TM05447-E3; TM05457-E3; TM06085-G3; TM06109-G3; TM06119-G3; TM06129-G3; TM06152-G3; TM06154-G3; TM06170-G3; TM06270-H3; TM06280-H3; TM06282-H3; TM06317-H3; TM06337-H3; TM06363-H3; TM06386-H3; CM12173-H1; CM03670-F0; CM10041-E1; CM10721-F1; CM17422-E2; CM14065-L1; CM01200-L9; CM10711-F1; CM13006-J1; CM09686-D1; CM16023-C2; CM07488-B1; CM06584-L0; CM14498-A2; CM11945-H1; CM09924-E1; CM10163-E1; TM0555733-E3; CM12712-I1; TM04453-B3; TM03615-A3; CM04707-I0; CM08494-C1; TM04593-B3; TM06051-F3; CM04641-I0; CM12252-H1; CM16585-D2; CM04089-H0; CM09094-D1; TM06056-F3; TM06057-F3; TM06060-F3; YM06061-F3; CM06521-L0; CM04176-H0; TM01305-H2; TM03623-A3; TM03637-A3; TM03631-A3; CM04739-I0; CM13335-J1; CM05366-J0; CM05379-J0; CM07674-B1; CM12608-I1; CM04078-H0; TM01934-I2; TM03605-A3; TM03614-A3; CM05787-K0; CM12519-I1; CM16699-E2; CM09685-D1; CM10622-F1; CM13227-J1; CM17680-E3; TM02741-K2; CM05243-J0; CM05992-K0; CM13985-L1; TM05504-E3; TM03338-L2; CM11689-H1; TM04360-B3; CM03934-G0; CM10757-F1; CM10768-F1; CM10771-F1; TM05692-E3; TM05710-E3; CM1099-L9; CM17684-F3; CM16059-C2; CM03133-E0; CM01660-C0; CM15956-C2; CM14371-LI; CM06098-K0; CM07733-B1; CM09173-D1; CM06805-L0; CM10013-E1; CM04005-G0; CM07697-B1; TM05835-F3; TM05840-F3; TM05854-F3; TM05872-F3; TM05905-F3; TM05912-F3; TM05921-F3; TM05947-F3; TM05956-F3; CM01797-C0; TM02210-J2; CM05139-J0; CM11127-F1; TM01614-H2; CM09611-D1; TM05714-E3; TM03476-A3; TM03627-A3; TM03684-A3; TM05824-E3; CM07628-B1.

Units Affected

202