FDA Medical Device Recalls (openFDA)
Spiegelberg Gmbh & Co. KG: 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.
- Recall number
- Z-2888-2016
- Recalling firm
- Spiegelberg Gmbh & Co. KG
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-12-29
- Posted
- not on file
- Terminated
- 2016-10-05
- Reason
- 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.
- Root cause
- Packaging
- Action
- Spiegelberg Gmbh & Co. KG sent an Urgent Medical Device Recall letter dated December 29, 2009, to all affected customers. Customers were instructed to quarantine and return stored products. Furthermore, they were asked to inform all their customers which have received the affected products and recall the products accordingly. Furthermore, they were asked to tell us about the actions taken by them.
- Quantity
- 22 units
- Distribution
- Nationwide Distribution to PA only
- Lot, serial or model codes
- Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393; Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
- 510(k) numbers
- ["K003759"]
- PMA numbers
- not on file
- Product code
- GWM
- Firm FEI
- 3002108226
- Firm city
- Hamburg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28