Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
FDA device recall Z-0597-2016 · posted 2016-01-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.
- Action taken
- Siemens sent an Important Customer Safety Notice dated November 17, 2015. The Notice identified the product, the problem, and the action to be taken by the customer. The potential issue will be remedied with a software update via Update Instructions AX067/15/S. Siemens service organization will contact customers to arrange a date for the installation of the software update. Customers with questions were advised to call 800-888-7436.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 73 units
- Distribution
- Nationwide Distribution including: AL, AZ, CA, CO, FL, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NC, NY, OH, OK, PA, SC, TN, TX, VA, and WI.
- Date initiated
- 2015-11-18
- Date posted
- 2016-01-06
- Date terminated
- 2016-12-05
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Syngo X-workplace SW VD10 (K143319) | Siemens Medi Cal Solutions, Inc. | 2015-02-24 |