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CT Gantry Cover

Pearl Technology AG · Model CT Gantry Cover S90 · UDI-DI 07640178062016

FMW Prescription

510(k) clearances

120

Adverse events (6 deaths)

Recalls

214

Facilities

Description

Reusable hygienic device shield for CT devices during invasive and non-invasive procedures to protect the CT device from penetrating fluids. Covers the lower half of the CT gantry. May only be used by medical personnel. Non-sterile and not to be used in the sterile field.

Recalls

Date	Firm	Reason
2014-08-11	Primus Medical LLC	The firm found that the top cover of the mattresses were delaminating.
2007-10-11	Invacare Corporation	In October 2007 Invacare Corporation, Florida recalled CareGuard Mattresses, Models CG10180 and CG10180A, associated with IVC Bed Series Full Electric Beds, Semi-Electric Beds and
2007-08-29	Invacare Corporation	In September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the

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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.