Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and I
FDA device recall Z-1307-2008 · posted 2008-07-02 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.
- Action taken
- On 2/15/07, AGFA notified their consignees of the situation by sending them "Urgent Medical Device Correction" letters, instructing them on how to work around the problem until the firm was able to install the upgraded software that corrected the problem. On 12/11/2007, the firm reported that the upgraded software had been installed at all affected sites.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 879 units
- Distribution
- Worldwide Distribution - USA including states of AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, KS, MA, MD, ME, MI, NC, NJ, NV, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA and WA, and country of Canada.
- Date initiated
- 2007-02-15
- Date posted
- 2008-07-02
- Date terminated
- 2009-06-30
- Location
- Greenville, SC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO (K022292) | Agfa Corp. | 2002-09-12 |