FDA Medical Device Recalls (openFDA)
Datex-Ohmeda, Inc.: Spacelabs flat panel monitor, Model 91415-A
- Recall number
- Z-0269-04
- Recalling firm
- Datex-Ohmeda, Inc.
- Product
- Spacelabs flat panel monitor, Model 91415-A
- Status
- Terminated
- Initiated
- 2003-10-29
- Posted
- 2004-07-20
- Terminated
- 2004-09-17
- Reason
- Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.
- 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
- 2734 units for domestic consignees and 1099 for international consignees
- Distribution
- The firm distributes to hospitals nationwide. The firm also distributes internationally.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K932724"]
- PMA numbers
- not on file
- Product code
- DXJ
- Firm FEI
- 3010157426
- Firm city
- Issaquah
- Firm state
- WA
- Firm country
- not on file
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
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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