Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900; (6) Aespire View; (7) Avance; (8) Avance CS2, GTIN 00840682102292; (9) Aisys; (10) Aisys CS2, GTIN 00840682102322; (11) Amingo; (12) 9100 NXT Config, Aelite NXT; (13) Protiva 7100;

Recall Insight

This FDA Devices action (record #Z-2596-2021) was formally reported on October 6, 2021, with the manufacturer initiating the action on August 2, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. GE Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records indicate Estimated 310,072 flow sensors units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volu… Distribution data in the federal record shows the product reached: Distribution was nationwide, including PR. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, B…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.