NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication syste
FDA device recall Z-2659-2016 · posted 2016-08-25 · Terminated
Recall details
- Recalling firm
- Novarad Corporation
- Reason for recall
- Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released.
- Action taken
- Novarad sent an Urgent Medical Device Correction letter dated August 12, 2016, to all affected consignees. As a workaround, customers are advised to use the HTMLS Viewer for review purposes only and not for diagnostic purposes. The issue has been fixed in all future releases of NovaPACS software. You can eliminate the possibility of incorrect information appearing by contacting Novarad Technical Supoort to arrange for an upgrade to a corrected version of NovaPACS software. This correction is available to all affected customers at no cost and will be included din all future upgrades. Customers will need to fax, mail, or email th eincluded Acknowledgement and Receipt Form back to Novarad. Customers with questions or concerens regarding this notification or would like to request an upgrade, should contact Novarad Technical Support at 801-221-5895. For questions regarding this recall call 801-642-1001.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 90
- Distribution
- Worldwide Distribution - US (Nationwide) Canada and other foreign consignees.
- Date initiated
- 2016-08-12
- Date posted
- 2016-08-25
- Date terminated
- 2017-02-22
- Location
- American Fork, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVAPACS (K132853) | Novarad Corp. | 2014-10-30 |