Recalls / —

—#35402

Product

Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02

FDA product code

DPS — Electrocardiograph

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K020708

Affected lot / code info

Software Versions A.01.01 or A.01.02

Why it was recalled

Software can generate printed ECG's that associate incorrect patient data with the waveform

Root cause (FDA determination)

Other

Action the firm took

Philips notified accounts by letter on 9/13/04 and advised users of the problem and will provide the software upgrade kit to version A.01.03.

Recalling firm

Firm

Philips Medical Systems

Address

3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern

Nationwide Australia, Brazil Korea, Japan, Mexico, Singapore,Taiwan,Canada, Belgium, Germany, Lebanon, Israel, Italy, Ireland, Netherlands, Oman, Spain, Saudia Arabia,Poland, Qtar,Switzerland, UAE, UK,

Timeline

Recall initiated

2004-10-13

Posted by FDA

2004-11-02

Terminated

2012-05-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #35402. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.