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Prone Face Cushion

MEDTEC, INC. · Model MTPFC01 · UDI-DI 00841439106983

IXQ Prescription
1
510(k) clearances
10
Adverse events (1 deaths)
7
Recalls
22
Facilities

Description

Reusable non-sterile (26.6 x 13.2 x 5cm) cushion

Recalls

DateFirmReason
2010-12-30Civco Medical Instruments IncSystems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to ri
2010-12-30Civco Medical Instruments IncSystems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to ri
2010-12-30Civco Medical Instruments IncSystems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to ri
2010-06-21Med Tec IncUnder certain conditions, the extensions can become detached from the main body of the couch.
2010-06-21Med Tec IncUnder certain conditions, the extensions can become detached from the main body of the couch.
2010-06-21Med Tec IncUnder certain conditions, the extensions can become detached from the main body of the couch.
2009-03-06Med Tec IncThe silkscreened indexing scale was reversed.

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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.