FDA Device recall Z-1700-2017
iConnect Enterprise Archive software
- FDA Device
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of iConnect Enterprise Archive software by Merge Healthcare, citing the versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in deter….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1700-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-04 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
iConnect Enterprise Archive software.
Reason
The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease.
Identifiers
| code_info | Versions 5.30.0, 5.30.1,5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E,…Versions 5.30.0, 5.30.1,5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560, 5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30, 8.30.2, 8.40.0, 8.40.1 HF0557, 8.40.2, 8.40.2.1, 8.40.2.2, 8.70 - Now Obsolete, 8.80 and Share 2.1, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.2.0, 9.3.0, 9.3.1, 9.4, 9.4.1, 9.4.2, 9.4.2.1, and 9.4.3. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1700-2017%22
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