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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE EFILM PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

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MERGE HEALTHCARE MERGE EFILM PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number MERGE EFILM V. 3.4
Device Problems Computer Software Problem (1112); Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2017
Event Type  Malfunction  
Manufacturer Narrative

The software defect identified in efilm v. 3. 4 which the customer was currently running was part of recall 2183926-09/20/2016-074-c (z-0707-2017) reported to the fda and has the potential to lead to inaccurate measurements. Use of this product may result in incorrect measurements on projection images of the sop classes listed above and the imager pixel spacing dicom tag and the pixel spacing tag. A user will likely be able to notice that the measurements are not as expected. The root cause of the recall was due to a code defect. Efilm workstation was using the imager pixel spacing dicom tag instead of the pixel spacing dicom tag, causing the measurements to be incorrect. Based on industry practice, if both the imager pixel spacing and pixel spacing dicom data is present and differs, the pixel spacing dicom tag should be used. A "measurement is approximate" message is now displayed when drawing line and ellipse measurements on uncalibrated images of the following types: · digital x-ray - for presentation · digital x-ray - for processing · digital mammography x-ray - for presentation · digital mammography x-ray - for processing · digital intra-oral x-ray - for presentation · digital intra-oral x-ray - for processing · x-ray angiographic image storage · enhanced xa image storage · x-ray radio-fluoroscopic image storage · enhanced xrf image storage. This defect is applicable to efilm workstation versions 2. 1, 3. 0, 3. 1, 3. 3, 3. 4, 4. 0 and 4. 1. The issue has been corrected in version 4. 1. 1 which was released september 28, 2016. Customer was informed the defect was corrected in efilm version 4. 1. 1 and above. Customer is unable to upgrade to current version of efilm 4. 2 because the operating system the customer is running is not compatible with the current version of efilm. When the customer upgrades to the minimum system requirements, the customer will be able to update their system to the fixed version of software.

 
Event Description

Efilm workstation is a software application that is used for viewing medical images. Efilm workstation receives digital images and data from various sources (including but not limited to ct, mr, us, rf units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). On (b)(6) 2017, a customer was concerned about a software defect identified in efilm v. 3. 4 which the customer was currently running. The defect was part of recall 2183926-09/20/2016-074-c (fda classification #: z-0707-2017) reported to the fda and has the potential to lead to inaccurate measurements. The issues does not impact all images, only specific projection images. Cr, dx, mg and xa images are the most common types of images and there were no issues related to these. Use of the recalled version of this product may result in incorrect measurements however, a user will likely be able to notice that the measurements are not as expected. The customer was informed the defect was corrected in efilm version 4. 1. 1 and above. The customer is unable to upgrade to current version of efilm 4. 2 because the operating system the customer is running is not compatible with the current version of efilm. When the customer upgrades to the minimum system requirements, the customer will be able to update their system to the fixed version of software. The customer did not indicate any inaccurate measurements were obtained with this product. Inaccurate measurements may result in a delay in patient care and/or change in recommendation for treatment, however, there is no indication that the issue, reported by the customer, resulted in a death or serious injury. (b)(4).

 
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Brand NameMERGE EFILM
Type of DevicePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge dr.
hartland, WI 53029
2623670700
MDR Report Key6806402
MDR Text Key83177286
Report Number2183926-2017-00172
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK020995
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMERGE EFILM V. 3.4
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/31/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0707-2017

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