Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-01-18 | Z-1211-2023 | Class II | Open, Classified | Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.Distribution: US Distribution was made to AL, CA, FL, IA, KY, LA, MN, NV, NC, OK, TX, VA, WA, and WV. There was no government/military distribution. Foreign distribution was made to Australia, Bahrain, Belgium, Germany, Great Britain, Italy, Netherland, Singapore, South Africa, Switzerland, and United Emirates Canada. | 335 stretchers (310 US, 25 OUS) | code info di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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