A loosening knob on an infant resuscitation system can deliver oxygen at a concentration other than the one set — only units serviced with a particular part (Datex-Ohmeda)

1For a newborn, too much oxygen is a problem as well as too little

A resuscitation system delivers a blend of oxygen and air to a newborn whose breathing has not established after birth. What matters here is that too little oxygen is not the only hazard. The record names hypoxia and hyperoxia side by side as harmful outcomes. For immature tissue in particular, excess oxygen imposes a burden of oxidative stress.

That is precisely why the device is built so a clinician sets, deliberately, what percentage is delivered.

2A fault where the setting and the reality diverge

This failure does not take the form of a device stopping or an alarm sounding. As the knob shaft loosens, the value on the dial and the concentration actually delivered come apart. To the user the device appears to be working and the number they set is visible. A fault in which display and reality diverge is different in kind from a shutdown — it is much harder to notice.

3"Only if the service part was fitted"

The record states that only units on which a specific service blender (M1091607-R) was installed at the last preventative maintenance are affected. Two devices of the same model can therefore differ in whether they are covered, depending on service history. The quantity is 550 units, of which 367 are in the U.S. and 183 outside it.

4One hundred and thirteen device records reached Japan

Of the FDA recall records this site holds as of 2026-09-01, 779 are devices, and 113 of those list Japan among the places distributed.

Roughly one in seven also reached Japan. The same model numbers travel across borders in medical devices, so a U.S. recall record can bear directly on a hospital elsewhere. Japan announces such matters under its own system, however, so a Japanese destination in the U.S. record does not mean the same notice appeared domestically.