| Class 2 Device Recall Merge PACS | |
Date Initiated by Firm | August 06, 2020 |
Create Date | September 09, 2020 |
Recall Status1 |
Terminated 3 on November 30, 2022 |
Recall Number | Z-2944-2020 |
Recall Event ID |
86205 |
510(K)Number | K192455 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | Merge PACS |
Code Information |
Unique Device Identifier (UDI): v8.1: PACS:(01)00842000100805(10)8.1(11)191022 OrthoPACS: (01)00842000100805(10)8.1(11)191022 v81.1: PACS: (01)00842000100805(10)8.1.1(11)200528 OrthoPACS: (01)00842000100805(10)8.1.1(11)200528 V8.1.2 PACS: (01)00842000100805(10)8.1.2(11)200709 |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
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For Additional Information Contact | Todd Brill 262-367-0700 |
Manufacturer Reason for Recall | Measurements done on the Merge PACS generated MPR s may have incorrect measurements. |
FDA Determined Cause 2 | Software design |
Action | The firm, IBM Watson Health, sent an "Urgent Field Safety Notice" dated 05 August 2020 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following:
Avoid incorrect pixel measurements by using the following workflow:
Step 1: Modality acquires a series and generates reformat and sends to Merge PACS
Step 2: Radiologist performs measurement on these series from the modality.
Avoid black dots that may lead to additional imaging by taking any of the following actions:
- Verifying study images either at modality or in another viewer.
- Increasing the window level will window out the lowest pixel value (the black dots).
- Viewing additional images/series within the study. Viewing of prior series/studies.
- Verifying patients history, diagnosis or other clinical data.
IBM Watson Health/Merge Healthcare will provide a software correction to address these issues. A representative will be in contact with you to schedule the software update.
Please ensure all potential users of Merge PACS v8.1, 8.1.1 and 8.1.2 have received this notice.
Please provide this notice to other organizations impacted by this action.
If you have any questions regarding this notice, please contact Customer Support at WHISupport@us.ibm.com or 877-741-5369. |
Quantity in Commerce | 125 total units |
Distribution | Domestic Distribution:
IL, MO, NY, ND, MI, TX, FL, OH, UT, NE, MS, MN, DE, AR, CA, WI, MD, NC, NH, GA, VA, SC, PE, CT, NM, IN.
International Distribution: CA, BE, UK. |
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
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