FDAFDA · Alimentos y medicamentos·N.º oficial Z-2888-2016
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
Publicado el 5 de octubre de 2016 · Inicio del retiro: 29 de diciembre de 2009
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Spiegelberg Gmbh & Co. KG
- Distribuidor
- Nationwide Distribution to PA only
- Lote
- Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393; Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Germany