GE Medical Systems Information Technologies Inc: PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- GE Medical Systems Information Technologies Inc
- Product
- PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
- Reason / hazard
- Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
- Recall initiated
- 2026-07-20
- Code info
- GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.
- Product quantity
- 15 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waukesha
- State
- WI
- Country
- United States
- Event id
- 99536
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