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Paper

Philips Medical Systems Hsg · Model Chemical/Thermal Paper · UDI-DI 10884838008387

DSF
10
510(k) clearances
6
Adverse events
1
Recalls
52
Facilities

Description

8.5"x11" Z-fold paper, no header Cardiograph thermal paper. Red Grid. 8.5x11" (216 mm x 279 mm). Pkg = 1 case = 8 packs = 1600 sheets Wgt= 18lbs 5 oz (8.31kg)

Recalls

DateFirmReason
2015-12-02Gsi Group IncThe item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.