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Philips Medical Systems Hsg · Model Thermal Array Paper · UDI-DI 00884838009486

DSF
10
510(k) clearances
6
Adverse events
1
Recalls
51
Facilities

Description

Thermal Array Paper Chemical/thermal paper, 10 rolls/box, roll length = 98 ft. (29.9m), width = 1.97 in (50mm), weight = 2 lbs (907g).

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.