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U.S. Department of Health and Human Services

Class 2 Device Recall Intracranial pressure monitor

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  Class 2 Device Recall Intracranial pressure monitor see related information
Date Initiated by Firm December 29, 2009
Create Date September 26, 2016
Recall Status1 Terminated 3 on October 05, 2016
Recall Number Z-2888-2016
Recall Event ID 75160
510(K)Number K003759  
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
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.
Code Information Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393;  Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
Recalling Firm/
Manufacturer		 Spiegelberg Gmbh & Co. KG
Tempowerkring 4
Hamburg Germany
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 22 units
Distribution Nationwide Distribution to PA only
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GWM and Original Applicant = AESCULAP, INC.
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