Carestream Recalls Kodak DirectView DR 7500 Dual Detector Systems
Carestream Health is recalling 164 Kodak DirectView DR 7500 Dual Detector Systems due to a possible patient image display error.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical imaging device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Carestream Health, Inc. has recalled the KODAK DirectView DR 7500 Dual Detector System, Model DR 7500, manufactured in the U.S.A. The recall involves 164 units in total, with 42 units distributed domestically in the United States and 122 units distributed internationally.
The recall was initiated due to a possible patient image display error associated with the utilization of Version 5.X Software. The affected units were distributed nationwide in the United States, including states such as Indiana, Pennsylvania, Maryland, Michigan, New York, Georgia, Minnesota, Oklahoma, Virginia, Texas, Wisconsin, California, Illinois, Tennessee, Washington, North Carolina, South Carolina, Massachusetts, New Jersey, and Kentucky. International distribution included Canada, New Zealand, South Korea, Australia, Hong Kong, Saudi Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, the United Kingdom, Sweden, Poland, Denmark, Germany, Finland, the Czech Republic, Italy, France, Portugal, and Spain.
Healthcare facilities and consumers should contact Carestream Health, Inc. for further information regarding the recall and corrective actions. The specific service code for this recall is 8087, and the associated catalog numbers are 8791345, 1155118, 1295088, 8551046, 1666700, and 8531675.
The recalled product
- Product
- KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
- Manufacturer
- Carestream Health, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Service Code: 8087
- Catalog numbers: 8791345
- 1155118
- 1295088
- 8551046
- 8791345
- 1666700
- 8531675
Distribution
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