Z-0269-04

Spacelabs flat panel monitor, Model 91415-A

Name: Z-0269-04 Spacelabs flat panel monitor, Model 91415-A
Creator: Datex-Ohmeda, Inc.
Published: 2003-10-29
License: https://open.fda.gov/license/

GE Healthcare / initiated 2003-10-29 / Terminated

FDA source

Datex-Ohmeda, Inc. began a recall of Spacelabs flat panel monitor, Model 91415-A on 2003-10-29. The reason FDA records is "Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0269-04
Status: Terminated
Initiated: 2003-10-29
Posted: 2004-07-20
Terminated: 2004-09-17
Recalling firm: GE Healthcare
Product: Spacelabs flat panel monitor, Model 91415-A
Product code: DXJ Display, Cathode-Ray Tube, Medical
Reason for recall: Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.
FDA root cause: Other
Action: A letter dated October 31, 2003 was sent on October 29-31, 2003 to all US customers via FED-EX. An ORDER FORM accompanied the letter for consignees to request a replacement power supply or to indicate they did not have the affected power supply.
Quantity in commerce: 2734 units for domestic consignees and 1099 for international consignees
Distribution: The firm distributes to hospitals nationwide. The firm also distributes internationally.
Product codes and lots: Date code range: 0001xx through 0152xx. All defective power supplies fall within the date code of week 1, 2000 and week 52, 2001. The date code can be found on the underside of the power supply, embossed at the top of the text. It will be in the format of 0108A3, which means ''01'' is the year 2001, ''08'' is week 8 and ''A3'' is the line A3.

Product code DXJ

K932724Class IISpacelabs Medical Integrated Clinical DisplaySpacelabs Medical, Inc. / cleared 1993-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)