CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray c
FDA device recall Z-0970-2013 · posted 2013-03-19 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- The cassettes were shipped with the wrong IP (image plate) size bar code.
- Action taken
- On February 7, 2013, AGFA called dealers involved to alert them of the safety issue. Also, an 'URGENT FIELD SAFETY NOTICE" letter dated February 26, 2013 was sent to the customers. The letter described the affected product, problem and actions to be taken. Customers were requested to check their inventories for the affected product and block any identified product within their inventory. Customers were instructed to complete the attached Feedback form and return via FAX or email. For questions call 877-777-2432 Prompt 5.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 17
- Distribution
- USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
- Date initiated
- 2013-02-07
- Date posted
- 2013-03-19
- Date terminated
- 2013-06-06
- Location
- Greenville, SC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CR 10-X DIGITIZER (K121948) | Agfa Healthcare N.V. | 2012-07-20 |