F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Reported: October 11, 2023 Initiated: September 8, 2023 #Z-2656-2023
Product Description
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Reason for Recall
There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.
Details
- Recalling Firm
- GE Medical Systems China Co., Ltd.
- Units Affected
- 1638 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Zealand, Oman, Poland, Qatar, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
- Location
- Wuxi, N/A
Frequently Asked Questions
What product was recalled? ▼
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms). Recalled by GE Medical Systems China Co., Ltd.. Units affected: 1638 units.
Why was this product recalled? ▼
There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-2656-2023.
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