Argus PB-3000 Monitor (Schiller) – measurement error (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Brand
Schiller, Ag Altgasse 68 Baar Switzerland
Lot Codes / Batch Numbers
REF: 1A.701307: UDI- 07613365003024 REF: 3.921002, UDI: 07613365001914 REF: 3.921030, UDI: 07613365003468 REF: 3.921031: UDI: 07613365003475 REF: 3.921006, UDI: 07613365000115 Affected Serial Numbers: 7010.000160 and lower, 7012.000356 and lower, 7013.000256 and lower, 7014.000152 and lower
Products Sold
REF: 1A.701307: UDI- 07613365003024 REF: 3.921002, UDI: 07613365001914 REF: 3.921030, UDI: 07613365003468 REF: 3.921031: UDI: 07613365003475 REF: 3.921006, UDI: 07613365000115 Affected Serial Numbers: 7010.000160 and lower, 7012.000356 and lower, 7013.000256 and lower, 7014.000152 and lower
Schiller, Ag Altgasse 68 Baar Switzerland is recalling Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006 due to Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.
Recommended Action
Per FDA guidance
On August 8, 2025, Schiller AG issued an Field Safety Notice to affected consignees via E-Mail. On September 6, 2025, Schiller issued a "Urgent Medical Device Recall Expansion their recall to additional products. Schiller asked consignees to take the following actions: 1. Read the Field Safety Notice (FSN) provided by the system manufacturer carefully 2. Wait until your system manufacturer contacts you for device testing or to arrange the remediation of your device(s). 3. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. (As appropriate) 4. Please transfer this notice to other organizations on which this action has an impact. (As appropriate) 5. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Please report all device-related incidents
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026