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Class 2 Device Recall Cardio Review Station (CRS) |
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| Date Initiated by Firm |
March 21, 2011 |
| Date Posted |
June 10, 2011 |
| Recall Status1 |
Terminated 3 on November 29, 2011 |
| Recall Number |
Z-2552-2011 |
| Recall Event ID |
58263 |
| 510(K)Number |
K050228
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| Product Classification |
System, image processing, radiological - Product Code LLZ
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| Product |
IMPAX CV (Cardio Vascular)
The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting. |
| Code Information |
Software versions - 2.01.B10, 2.01.B15, 2.01.B25, 2.02.B32, 2.02.B39 2.02.B40, 2.02.B43, 2.03.B16, 2.02.B23, 2.03.B26, 2.03B31.P01, 2.03.B31, 2.04.B03, 2.04.B06, 2.05.B01, 2.04.B07, 2.06.47, 2.06.47.02, 2.05.B02, 2.06.47.08, 2.06.47.08, 2.06.47.08.03, 2.06.47.02, 2.06.47.18, 2.06.47.18.01, 2.06.47.27, 2.06.47.18.02, 2.06.47.30, 2.06.47.37, 2.06.47.40, 2.07.24, 2.08.05.01, 2.07.30.01, 2.07.30.02, 2.05.03.04, 2.09.03, 2.07.30.07, 2.07.35, 2.07.24.SLEH.07, 2.09.04.02, 2.07.35.01, 2.10.06, 2.11.06, 2.05.04.05, 2.12.09, 2.13.08, 2.13.08.SU1, 2.14.03, 2.14.03.SU1, 2.15.08, 2.14.03.SU2, 2.15.08.SU3, 2.16.08, 7.4.SU3, 7.8, 7.8.SU1, and 7.8.SU2 |
Recalling Firm/
Manufacturer |
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
|
| For Additional Information Contact |
Jeffery A. Jedlicka
864-421-1815
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Manufacturer Reason
for Recall |
Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm, AGFA Healthcare, sent an "URGENT SAFETY NOTICE" letter dated March 21, 2011 via FED-EX to its customers.. The letter describes product, problem, and actions to be taken. The customers were instructed to distribute this information within their facility to all individuals who need to be aware and to complete and return the URGENT SAFETY NOTICE FEEDBACK FORM via fax to: 864-421-1664 or email.
AGFA is supplying the customers with a CRS User Manual Addendum to emphasize the proper steps required to achieve an accurate measurement when using the calibration tool within CRS. Mitigation will provide the customer/end-user with awareness of the correct XA measurement calibration technique and the potential consequences if proper technique is not followed. Additionally, AGFA will offer customer training on the use of the calibration tool. This training will be provided remotely via the web at no cost. Customers were ask to register before May 1, 2011 by contacting AGFA Customer Support Center toll-free at 877-777-2432. Training sessions are from May-June 2011.
If you have any questions about this matter, please contact your local AGFA HealthCare organization or the AGFA Customer Support Center at 877-777-2432. |
| Quantity in Commerce |
536 |
| Distribution |
Worldwide distribution: USA (nationwide) and country of Canada. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
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