Home › CARESTREAM HEALTH, INC. › INSIGHT
INSIGHT
CARESTREAM HEALTH, INC. · Model INSIGHT · UDI-DI 40889971079080
10
510(k) clearances
13
Adverse events
13
Recalls
52
Facilities
Description
INSIGHT 150PKT 30.5x40.5 film IP22 PR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-25 | Agfa N.V. | Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in dif |
| 2014-10-24 | AGFA Healthcare Corp. | Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed. |
| 2014-07-16 | AGFA Healthcare Corp. | Some sheets of the medical screen film are fogged. |
| 2014-07-02 | Carestream Health Inc. | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may ca |
| 2014-07-02 | Carestream Health Inc. | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may ca |
| 2013-01-17 | Carestream Health, Inc. | Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing |
| 2011-12-20 | Carestream Health, Inc. | Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density. |
| 2011-10-04 | AGFA Corp. | The film notch was located in the wrong position. |
| 2010-03-12 | Carestream Health, Inc. | Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like |
| 2010-03-12 | Carestream Health, Inc. | Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.