Stryker Endoscopy: PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614,

Is my product affected?

PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device t

• UPC 000505052795

Check against the official notice below — it lists the full affected range.

What happened

Stryker Endoscopy has recalled 489 PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator units worldwide. When these devices operate in high flow mode at 40L/min with 15 mmHg pressure while connected to a house gas inlet source, the flow rate drops to 0L/min within seconds of insufflating, and a red "Check Gas Supply" symbol appears on the display, immediately stopping insufflation. The affected units have specific lot numbers and serial numbers, with distribution across numerous countries including the United States, Puerto Rico, China, Japan, Korea, India, Vietnam, and many others.

The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.

Details from the source

Reason for recall: When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation. Distribution: Worldwide distribution. US nationwide including Puerto Rico, China, Hong Kong, India, Japan, Korea, Romania, Vietnam, Singapore, Taiwan, Netherlands, Peru, Australia, Canada, Mexico, Argentina, Chile, Poland, South Africa, and Guatemala. Quantity: 489 Lot/code info: HPUs affected lot numbers 0005051337-000505052795; PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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