DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL,
FDA device recall Z-0213-2012 · posted 2011-11-18 · Terminated
Recall details
- Recalling firm
- Cooper Surgical, Inc.
- Reason for recall
- The DICOM Software, Norland Illuminatus DXA Software with the DICOM Option (Part Number 434A133) version 4.2.0 through 4.3.1, which is installed on the XR-600, XR-800, XR-46 and EXCELL DXA Bone Densitometers, could lead to improper patient information getting into a previous patient's record.
- Action taken
- The firm, CooperSurgical, sent a "Notice of RECALL-URGENT" letter dated September 23, 1011 to its customers. The letter described the product, "Problem/Situation", and "When can this problem occur?". CooperSurgical will send a new revision of Illuminatus software to the customers once available. If you have any concerns about your existing database of patients, please contact our Norland Technical Support team at (203) 601-5200 Extension 9888 or 9889.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KGI
- Quantity affected
- 184
- Distribution
- Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, FL, GA, IN, KS, KY, LA, MD, MA, MI, MO, NJ, NY, NC, OK, PA, TN, TX, UT, and WI ; and countries of: ARGENTINA, AUSTRALIA, BELGI
- Date initiated
- 2011-09-23
- Date posted
- 2011-11-18
- Date terminated
- 2013-04-09
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 (K992125) | Norland Medical Systems, Inc. | 1999-11-22 |