SIEMENS Urgent Field Safety Notice September 2014 Damaged Power Supply Adaptor – Discontinue Use Immediately

Siemens Healthcare Diagnostics has received customer complaints regarding damage to the
external power supply adaptors that accompany the CLINITEK Status®, CLINITEK Status®+,
and CLINITEK Status® Connect urine analyzers, which can result in an increased potential for
electric shock to the user.

SIEMENS

Urgent Field Safety Notice
31983 Rev. A
September 2014
CLINITEK Status®, CLINITEK Status®+, and CLINITEK Status® Connect Systems
Damaged Power Supply Adaptor – Discontinue Use Immediately
Our records indicate that your facil ity may have received the fol lowing products that could
potentially contain a damaged power supply:

Table 1. CLINITEK® Affected Product(s)
Siemens Material Number (SMN) Product Description
10379675; 10379676; 10379677;
10379678; 10379679; 10379680; CLINITEK Status+ 10379681; 10697813: 10376324;
(Legacy P/N: 1780)
10376322; 10376323 (Legacy P/N: 1790); CLINITEK Status Connect System 104 70849 (Legacy P/N: 1797)
10378632; 10378633; 10378634; CLINITEK Status Power Supply Adaptor – 10309177; 10309178; 10324040;
10376820 Spare Part

Reason for this Safety Notice:
Siemens Healthcare Diagnostics has received customer complaints regarding damage to the
external power supply adaptors that accompany the CLINITEK Status®, CLINITEK Status®+,
and CLINITEK Status® Connect urine analyzers, which can result in an increased potential for
electric shock to the user. This also includes orderable spare parts.

This affects power supply adaptors embossed with the following numerical date codes:
50130, 51130, 52130,01140,02140,03140,04140,05140,06140,07140,08140,09140,
10140, 11140, 12140, 13140, 14140, 15140, 16140, 17140, 18140, 19140,20140,21140,
22140, 23140.

Figure 1. Date Code Location and Identification
Example date code located on the side of the power supply
adaptor, shown here as 03140
Siemens Healthcare Diagnostics Inc. AU Rights Reserved.
511 Benedict Ave.
Tarrytown, NY 10591
www.slemens.com/diagnostics

GPF-003 -6 V5. 1 Effective: 2014-07-07
Related Procedure: GP-003 DX-Field Action
Page 1of3

Urgent Field Safety Notice 31983-September 2014
Mailing Number 14-64 Damaged Power Supply Adaptor – Discontinue Use Immediately
Risk to Health

A damaged power supply adaptor could result in an increased potential for electric shock to the
user.
Actions to be Taken by the Customer
For the products listed in Table 1, please perform the following steps:
1. TURN OFF the device and disconnect the power supply adaptor from the wall outlet
before inspecting the power supply adaptor case.
2. Upon checking the power supply case you will be able to identify an embossed date
code (Figure 1 ).
3. If your power supply adaptor is embossed with one of the date codes indicated above,
immediately discontinue use, discard the power supply adaptor, fill out the attached Field
Correction Effectiveness Check form, and return the completed form to your local
Siemens Customer Care Center.
4. If your power supply adaptor has a date code that is not indicated above, but the case is
cracked or damaged in any way (Figure 2), immediately discontinue use, discard the
power supply adaptor, fill out the attached Field Correction Effectiveness Check form,
and return the completed form to your local Siemens Customer Care Center.
Figure 2. Example of Potential Case Damage
1
1 Simulated broken power supply adaptor case
If you are a CLINITEK Status or CLINITEK Status+ customer, you may continue to run your
instrument using battery power. Please consult your Operator’s Guide for instructions.
CLINITEK Status Connect systems, however, cannot be operated on battery power.
We apologize for the inconvenience this situation may cause. If you have any questions, please
contact your Siemens Customer Service Center or your local Siemens technical support
representative.

Please retain this letter with your laboratory records, and forward this letter to those who may
have received this product.
CLINITEK Status, Status+, and CLINITEK Status Connect are trademarks of
Siemens Healthcare Diagnostics.
Siemens Healthcare Diagnostics Inc. All Rights Reserved.
511 Benedict Ave.
Tarrytown. NY 10591
www.siemens.com/diagnostics
GPF-003 -6 V5.1 Effective: 2014-07-07
Related Procedure: GP-003 DX-Field Action
Page 2 of 3
Urgent Field Safety Notice 31983 – September 2014
Mailing Number 14-64