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Saltillo
PRENTKE ROMICH COMPANY · Model TouchChat App · UDI-DI 00816486021015
LNX
Prescription
1
510(k) clearances
590
Adverse events (16 deaths)
21
Recalls
0
Facilities
Description
TouchChat HD w/ WordPower App
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-12-03 | Baxter Corporation Englewood | Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due to the possibility tha |
| 2013-11-20 | Sorin Group Italia S.r.l. | Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a |
| 2011-10-25 | SCC Soft Computer | On 10/25/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. When SoftReports Designer opened a |
| 2011-06-13 | SCC Soft Computer | On 06/13/2011, SCC Soft Computer initiated a correction on the following SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. A client reported when they verified the contents |
| 2011-05-03 | SCC Soft Computer | On 05/03/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the following SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. A client repo |
| 2011-03-22 | SCC Soft Computer | Potential for patient data to be sent to the wrong patient record. A software change affected how the Softlab handles recovery from certain types of table access conflicts. When s |
| 2010-07-19 | SCC Soft Computer | Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft C |
| 2010-06-23 | SCC Soft Computer | SCC Soft Computer is issuing a correction for SoftReports Versions 1.1.6.x released 02/2008 and 1.1.7.x released 06/2008. Potential hazard - when using SoftReports Layout Designer |
| 2009-08-28 | SCC Soft Computer | SCC Soft Computer issued a Correction for SoftID.NET versions 2.0.0.6 - 2.0.0.19. When using the Cancel functionality, if the collection list refreshes during the transaction and |
| 2009-01-26 | SCC Soft Computer | For SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4., the Previous Patient History and some QA Management reports may have missing or incorrect diagnosis text. However |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.