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LINEAR IV
CARESTREAM HEALTH, INC. · Model LINEAR IV · UDI-DI 60889976573778
1
510(k) clearances
9
Adverse events
3
Recalls
17
Facilities
Description
R40-CS-P LIN IV COLLIMATOR W/65 FT CABLE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-10-28 | Shimadzu Medical Systems | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standard |
| 2008-02-07 | Philips Medical Systems North America Co. Phillips | The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath. |
| 2007-03-15 | Philips Medical Systems North America Co. Phillips | The Collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. System is non-compliant with performance standard (1020.31 (d)(2)(iii) 21 |
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Get your free API keyRead the docsData 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.