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

Recall number

Z-1050-04

Recalling firm

Datascope Corp

Product

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

Status

Terminated

Initiated

2004-04-05

Posted

2004-07-20

Terminated

2005-01-19

Reason

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

Root cause

Other

Action

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

Quantity

202

Distribution

The units were shipped to hospitals and clinics nationwide. Also to Australia, Brazil, Belgium, France, Germany,Turkey, United Kingdom, United Arab Emirates. One unit was shipped to the VA Medical Center, Augusta, GA.

Lot, serial or model codes

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.

510(k) numbers

["K993531"]

PMA numbers

not on file

Product code

MSX

Firm FEI

2221819

Firm city

Mahwah

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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